Siemens Healthcare Diagnostics Inc.

FDA Device Registration & Listing · Tarrytown, NY, US · Registration 2432235

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2432235
FEI Number
2432235
Entity Name
Siemens Healthcare Diagnostics Inc.
City/State/Country
Tarrytown, NY, US
Establishment Address
511 Benedict Ave, Tarrytown, NY 10591, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SIEMENS HEALTHCARE DIAGNOSTICS INC. (Owner Number: 9096044)
Owner / Operator Contact Address
Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue, Tarrytown, NY 10591, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K181082
PMA Number
N/A

All Registered Proprietary Names

Atellica CH A1c_EZ PRE Atellica CH Enzymatic Hemoglobin A1c (A1c_E) ADVIA Chemistry A1c_E Reagent (4x300 Kit) ADVIA Chemistry A1c_E Pretreatment Buffer Kit ADVIA Chemistry A1c_E Reagent (2x150 Kit) ADVIA Chemistry Creatine Kinase (CK_L) Assay Atellica IM Total Triiodothyronine (T3) Atellica IM Total Triiodothyronine Diluent (T3 DIL) ADVIA Centaur Total Triiodothyronine Diluent (T3 DIL) ADVIA Centaur Acid and Base Reagents ADVIA Centaur Total Triiodothyronine (T3) ADVIA Centaur XP Analyzer ADVIA Centaur Total Triiodothyronine Master Curve Material (T3 MCM) Atellica IM Total Triiodothyronine Master Curve Material (T3 MCM) ADVIA Centaur CP Analyzer Atellica IM Probe Wash 3 (PW3) ADVIA Centaur HIV Ag/Ab Combo Quality Control Kit (CHIV QC) ADVIA Centaur HIV Ag/Ab Combo (CHIV) Atellica IM HIV Ag/Ab Combo (CHIV) Atellica IM HIV Ag/Ab Combo Quality Control Kit (CHIV QC) ADVIA Centaur Enhanced Estradiol Diluent (eE2 Dil) Atellica IM Enhanced Estradiol Diluent (eE2 DIL) Atellica IM Enhanced Estradiol (eE2) ADVIA Centaur Enhanced Estradiol (eE2) Atellica IM Hepatitis A Total (HAVT) Atellica IM Hepatitis A Total Quality Control (HAVT QC) ADVIA Centaur Hepatitis A Total Quality Control (HAVT QC) Atellica CH Enzymatic Creatinine_2 (ECre_2) ADVIA Centaur Atellica IM RapidQC Plus Blood Gas Systems Controls Atellica IM aTPOII Diluent (aTPOII DIL) Atellica IM aTPOII Quality Control (aTPOII QC) Atellica IM aTPOII Master Curve Material (aTPOII MCM) ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM) ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) ADVIA Centaur aTPOII Diluent (aTPOII DIL) ADVIA Centaur aTPOII Quality Control (aTPOII QC) Atellica IM Anti-Thyroid Peroxidase II (aTPOII) IMMULITE 2000 Ferritin (FER) Cinnamon (F220L2); Flounder (F147L2); Brewer's Yeast (F403L2); Cantaloupe (F102L2); Halibut (F303L2); Mushroom (F212L2) Green Bean (F315L2); Green Pepper (F263L2) IMMULITE 2000 3gAllergy Specific IgE Sugar Cane (F21L2); Yogurt (F360L2) Pinto Beans (F300L2); Red Kidney Bean (F287L2) IMMULITE 2000 Free PSA (fPS) IMMULITE 2000 Mixed Allergen Panels ADVIA ADVIA Chemistry Atellica CH Rheumatoid Factor (RF) BN II Additive N Predilution Wells N Evaporation Caps for Control Vials (2.5 mL) BN ProSpec System CLEANER SCS N Cuvettes Segments for BN ProSpec Emi II Plus Methadone Assays Atellica CH Methadone (Mdn) Atellica CH Methadone (MdnC) TECHNICON STAR SYSTEM MAGIC LITE ANALYZER ADVIA ADVIA Chemistry ADVIA 120 Atellica CH Phencyclidine (Pcp) Assay Atellica CH Vancomycin (Vanc) Assay Atellica CH Phencyclidine (PcpC) Atellica IM DHEA-SO4 Master Curve Material (DHEAS MCM) ADVIA Centaur DHEA-SO4 Master Curve Material (DHEAS MCM) Atellica HEMA 580 Analyzer ADVIA Centaur Atellica IM Digoxin (DIG) ADVIA Centaur Digoxin (DIG) ADVIA Centaur CA 15-3 III ADVIA Centaur CA 15-3 Calibrator (CA 15-3 CAL) Dimension FT3 Flex MAGIC LITE T3 100 TEST KIT IMMULITE 2000 Total T3 (T3) Dimension Vista FT3 Flex Atellica CH Magnesium (Mg) ADVIA Hematology ADVIA Chemistry Salicylate (SAL) Atellica CH Salicylate (Sal) Atellica CH Salicylate (SalC) IMMULITE 2000 Androstenedione (AND) Atellica IM Zika IgM 50T/100T ADVIA Centaur Zika Ab Atellica IM Zika IgM Controls/Ab Controls ADVIA Centaur Zika IgM ADVIA Centaur Zika Ab Controls ADVIA Centaur Zika IgM Controls ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH ADVIA 60 ADVIA Hematology Ictotest ADVIA Centaur anti-CCP IgG (aCCP) Atellica IM anti-CCP IgG (aCCP) ADVIA Centaur Atellica IM Toxoplasma IgG Quality Control (Toxo G QC) Atellica IM Toxoplasma IgG (Toxo G) BAYER 1650 APOLIPOP N Latex ASL Dimension Vista ASL Flex Atellica CH Anti-Streptolysin-O_2 (ASO_2) Atellica CH Anti-Streptolysin-O_3 (ASO_3) ADVIA Chemistry ADVIA Atellica IM Enhanced Estradiol Master Curve Material (eE2 MCM) ADVIA Centaur Enhanced Estradiol Master Curve Material (eE2 MCM) ADVIA Atellica IM aTgII Master Curve Material (aTgII MCM) ADVIA Centaur aTgII Quality Control (aTgII QC) Atellica IM Anti-Thyroglobulin II (aTgII) Atellica IM aTgII Quality Control (aTgII QC) ADVIA Centaur aTgII Master Curve Material (aTgII MCM) ADVIA Centaur Anti-Thyroglobulin II (aTgII) IMMULITE 2000 ACTH (ACT) ADVIA 120 ADVIA 2120 ADVIA 120/2120 CUVETTES ADVIA Centaur Systems Cuvette ADVIA Centaur Prostate-specific Antigen (PSA) Atellica IM CAL Q Atellica IM Prostate-specific Antigen (PSA) Atellica CH Microalbumin_2 Calibrator (?ALB_2 CAL) ADVIA ADVIA Chemistry Atellica CH Creatinine_3 (Crea3) IMMULITE 2000 Multi-Diluent 2 ADVIA Centaur Multi-Diluent 3 (M-Dil 3) ADVIA Centaur Multi-Diluent 11 (M-Dil 11) Blood Gas Systems 600 Series Blood Gas ADVIA Centaur Multi-Diluent 15 IMMULITE 2000 IgG/IgM Sample Diluent Atellica IM Multi-Diluent 12 (M-Dil 12) Atellica IM Multi-Diluent 13 (M-Dil 13) Atellica IM Multi-Diluent 2 (M-Dil 2) Atellica IM Multi-Diluent 1 (M-Dil 1) Atellica IM Multi-Diluent 10 (M-Dil 10) Atellica IM Multi-Diluent 11 (M-Dil 11) Atellica IM Multi-Diluent 3 (M-Dil 3) Atellica IM Multi-Diluent 15 (M-Dil 15) ADVIA Centaur Multi-Diluent 10 (M-Dil 10) ADVIA Centaur Multi-Diluent 1 (M-Dil 1) Atellica HEMA Diluent (HEMA Diluent) IMMULITE 2000 Multi-Diluent 1 ADVIA Centaur Multi-Diluent 2 (M-Dil 2) MAGIC LITE INTACT PTH DILUENT Atellica IM CMV IgG QC ADVIA Centaur CMV IgG (CMV IgG) assay Atellica IM CMV IgG (CMV IgG) assay ADVIA Centaur CMV IgG (CMV IgG) Quality Control Atellica CH ?2-Microglobulin (B2M) Atellica CH ?2-Microglobulin Calibrator (B2M CAL) Atellica CH Diazo Direct Bilirubin (D_DBil) Dimension Vista IGA Flex Dimension Vista IGM Flex Atellica CH A1c_3 Calibrator (A1c_3 CAL) ADVIA Chemistry HbA1c Denaturant Reagent (HbA1c Denat) Atellica CH Diazo Total Bilirubin (D_TBil) Atellica® CH N-acetylprocainamide (NAPA) Dimension NAPA Flex Dimension Vista PREALB Flex N Antiserum to Human Prealbumin Atellica CH Prealbumin (PALB) Atellica IM total PSA II (tPSAII) Atellica CH Chemistry Calibrator (CHEM CAL) ADVIA Chemistry Lithium_2 (LITH_2) Atellica CH Lithium_2 (LITH_2) Emit 2000 Carbamazepine Cals Emit 2000 Carbamazepine Assay ADVIA Chemistry Atellica CH Total Iron Binding Capacity (TIBC) Total IgE Control Module IMMULITE Total IgE Control Module (TIE QC) ADVIA Chemistry Atellica CH Liquid Specific Protein Calibrators (LSP CAL) ADVIA ADVIA® Chemistry Toxicology Calibrators Dimension Drug Cal II Dimension Vista DRUG 2 Cal Atellica IM free PSA II (tPSAII) ADVIA Chemistry ADVIA Centaur Alpha Fetoprotein Master Curve Material (AFP MCM) ADVIA Centaur Calibrator D ADVIA Centaur HCV Atellica IM aHCV ADVIA Chemistry Atellica CH A-LYTE IMT Cleaner Dimension Vista® Acid Clean Flex® reagent cartridge ADVIA Centaur ADVIA Centaur Anti-Thyroglobulin (aTG) Atellica IM Calibrator 1 (Cal 1) ADVIA Centaur Calibrator 1 (Cal 1) Atellica IM aTG Quality Control (aTG QC) ADVIA Centaur aTG Diluent (aTG Dil) ADVIA Centaur aTG Quality Control (aTG QC) Atellica IM aTG Diluent (aTG Dil) Atellica IM Anti-Thyroglobulin (aTG) Atellica IM Anti-Thyroglobulin Master Curve Material Set (aTG MCM) ADVIA 2120 and ADVIA 2120i Aspiration pathway Wash Kit ADVIA 2120 and ADVIA 2120i RBC Flow Cell Wash Kit Neodisher GK ADVIA 2120 and ADVIA 2120i Perox Flow cell wash kit ADVIA 2120 and ADVIA 2120i Vent Line Wash Kit Emit II Plus Propoxyphene Assays Atellica CH Propoxyphene (Ppx) Atellica CH Cannabinoids THC (ThcC) Emit II Plus Cannabinoid Assays Atellica CH Cannabinoids THC (Thc) ADVIA Chemistry wrCRP Reagents ADVIA ADVIA Chemistry Atellica CH Glucose Hexokinase_3 (GluH_3) ADVIA Atellica IM Carcinoembryonic Diluent (CEA DIL) ADVIA Centaur Carcinoembryonic Diluent (CEA DIL) ADVIA Centaur CEA Master Curve Material (CEA MCM) Atellica IM Carcinoembryonic Antigen Master Curve Material Set (CEA MCM) ADVIA Centaur XPT System Dimension Vista A1AG Flex Atellica CH Alpha-1-acid Glycoprotein (AAG) IMMULITE 2000 Herpes I & II IgG (HVG) ADVIA Centaur Vitamin D Total (VitD) Atellica IM Vitamin D Total (VitD) ADVIA Chemistry Atellica CH Immunoglobulin A_2 (IgA_2) Atellica CH Apolipoprotein A-1 (APO A1) Atellica CH Apolipoprotein B (APO B) Atellica CH Immunoglobulin G_2 (IgG_2) Atellica CH Transferrin (Trf) Atellica CH Immunoglobulin M_2 (IgM_2) Atellica IM CMV IgM Quality Control (CMV IgM QC) Atellica IM CMV IgM (CMV IgM) IMMULITE 2000 CMV IgM (CMM) ADVIA Centaur CMV IgM (CMV IgM) ADVIA Centaur CMV IgM Quality Control (CMV IgM QC) Atellica IM Free Thyroxine (FT4) Atellica IM Free Thyroxine Master Curve Material (FT4 MCM) ADVIA Centaur Free Thyroxine (FT4) ADVIA Chemistry Special Chemistry Calibrator (SPCL CHEM) Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 Atellica CH DRUG CAL II Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 Emit 2000 Phenytoin Assay Emit 2000 Phenytoin Cals Atellica CH High Sensitivity C-Reactive Protein Calibrator (hsCRP CAL) Atellica CH High Sensitivity C-Reactive Protein (hsCRP) ADVIA Chemistry Atellica® CH Calcium_2 (CA_2) ADVIA Chemistry Calcium_2 Reagents (CA_2) Atellica CH Acetaminophen (Acet) ADVIA ADVIA Chemistry Atellica CH Acetaminophen (AcetC) ADVIA Centaur Dimension CRBM Flex Atellica CH Carbamazepine (Carb) ADVIA Centaur IMMULITE 2000 Specific Allergens ADVIA Centaur ADVIA CENTAUR TOXOPLASM Atellica IM Toxoplasma IgM (Toxo M) Atellica IM Toxoplasma IgM Quality Control (Toxo M QC) REGULATOR. PRESSURE GAS CYLINDER ADVIA Chemistry Albumin BCP (ALBP) ADVIA Chemistry Albumin BCP CAL (ALBP CAL) Atellica CH Lactate Dehydrogenase L-P (LDLP) Dimension LDI Flex DM Vista LDI ADVIA Chemistry LDLP ADVIA Chemistry LDPL ADVIA Chemistry LAC ADVIA Centaur Follicle Stimulating Hormone Master Curve Material (FSH MCM) Atellica IM Follicle Stimulating Hormone Master Curve Material (FSH MCM) ADVIA ADVIA 1650 GAMMA GLUTAMYL T ADVIA Hematology ADVIA Chemistry ADVIA ADVIA 120/2120 ADVIA Chemistry CHE ADVIA Centaur Luteinizing Hormone (LH) Atellica IM Luteinizing Hormone (LH) ADVIA Centaur Luteinizing Hormone Master Curve Material (LH MCM) IMMULITE Calcitonin Control Module (CAL QC) IMMULITE 2000 Calcitonin (CAL) IMMULITE 2000 Intact PTH (iPT) IMMULITE 2000 Intact PTH Sample Diluent (iPT DIL) IMMULITE Intact PTH Control Module (iPT QC) Atellica IM Folate Assay (FOL) Atellica IM Folate Diluent (FOL DIL) Atellica IM Folate RBC (Fol RBC) Atellica IM Folate DTT/Releasing Agent (Fol DTT/REL) IMMULITE PSA Calibration Verification Material (PSA CVM) Atellica IM HIV Ag/Ab Combo (CHIV) IMMULITE CMV IgG Control Module IMMULITE IMMULITE CMV IgG IMMULITE CMV IgG Control Module (CVG QC) ADVIA Centaur Atellica IM T3/T4/VB12 Ancillary Reagent Dimension TGL Flex Atellica CH Triglyceride_2 (Trig_2) Atellica IM Calibrator E (CAL E) Atellica IM Progesterone (PRGE) ADVIA Centaur Calibrator E (CAL E) ADVIA Centaur Progesterone (PRGE) IMMULITE 2000 TSH Sample Diluent (TSH DIL) IMMULITE 2000 Rapid TSH (RTH) ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Atellica IM Active-B12 (Holotranscobalamin) (AB12) ADVIA Centaur ADVIA Centaur Intact PTH IPTH) Dade Innovin ADVIA Centaur Hepatitis B surface Antigen Quality Control (HBs QC) ADVIA Centaur Hepatitis B surface Antigen Confirmatory (HBsAg Conf) IMMULITE 2000 Free T4 (F4) IMMULITE 2000 Systems Third Generation TSH ADVIA Chemistry TRIG_2 Atellica CH Triglycerides_2 (TRIG_2) ADVIA Chemistry TRIG_c Atellica CH IMT Standard A (IMT Standard A) Atellica CH Reagent Probe Cleaner 1 (RPC1) Atellica CH 930 Analyzer Atellica CH Cleaner Atellica CH EMPTY Atellica CH Reagent Probe Cleaner 4 (RPC4) Atellica CH Lamp Coolant (LC) Atellica CH IMT Standard B + Salt Bridge (IMT Standard B + Salt Bridge) Atellica CH Water Bath Additive (WBA) Atellica CH IMT Diluent (IMT Diluent) Atellica Direct Load Atellica CH Reagent Probe Cleaner 2 (RPC2) Atellica CH Diluent Atellica CH IMT Dilution Check (IMT Dilution Check) Atellica CH Check Reagent (CHK) Atellica CH Albumin BCP Calibrator (AlbP CAL) Atellica CH Wash Atellica CH Conditioner Atellica CH EMPTY1 Atellica CH HA1c_E High Volume Labels (50) Atellica CH EMPTY2 Atellica CH HA1c_E High Volume Bottles (5) Atellica CH HA1c_E High Volume Conversion Kit Atellica CH Lid Keying Feature Atellica CH 930 Analyzer (Fully Refurbished) Atellica IM BR 27.29 Pretreatment Reagent (BR PRE) Atellica IM BR 27.29 Calibrator (BR CAL) ADVIA Centaur Pretreatment Reagent (BR PRE) ADVIA Centaur Calibrator G (CAL G) Atellica IM BR 27.29 Master Curve Material Set (BR MCM) ADVIA Centaur BR Master Curve Material (BR MCM) ADVIA Chemistry Enzymatic Creatinine_3 (ECre3) Atellica CH Enzymatic Creatinine_3 (ECre3) Atellica IM Anti-Hepatitis B core Total (HBcT) Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC) Kit ADVIA Centaur Anti-Hepatitis B core Total (HBcT) ADVIA Centaur Anti-Hepatitis B core Total Quality Control (HBcT QC) Kit DCA Systems DCA Vantage ADVIA Centaur CA 15-3 (CA15-3) Atellica IM CA 15-3 Calibrator (CA15-3 CAL) Atellica IM CA 15-3 (CA15-3) Atellica IM CA 15-3 Master Curve Material Set (CA 15-3 MCM) IMMULITE 2000 C-Peptide (PEP) ADVIA Centaur C-peptide (CpS) Atellica IM C-peptide (CpS) ADVIA Centaur Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) ADVIA Chemistry ADVIA Centaur C-peptide Master Curve Material (CpS MCM) Atellica IM C-peptide Master Curve Material (CpS MCM) ADVIA Centaur Atellica IM Rubella IgG Quality Control (Rub G QC) Atellica IM Rubella IgG (Rub G) ADVIA Centaur Anti-Hbe2 (aHBe2) Atellica IM Anti-HBe2 (aHBe2) ADVIA ADVIA 1650 CREATINE KINASE ASSAY Atellica HEMA Calibrator ADVIA Centaur IgE Diluent (IgE Dil) RAPID QC Complete RAPID QC CVM ADVIA Centaur TSH3-Ultra (TSH3ULII) Atellica IM TSH3-Ultra (TSH3ULII) ADVIA Centaur Atellica IM ADVIA Hematology ADVIA 560 Control Set (L-N-H) ADVIA 360 Control Set (L-N-H) IMMULITE 2000 ANTI-TPO Atellica CH DRUG CAL (DRUG CAL) Dimension Drug Cal ADVIA Hematology IMMULITE 2000 Rubella Quantitative IgG (RUB) IMMULITE Rubella IgG Control Module (RUB QC) ADVIA Centaur Atellica IM ADVIA 120 ADVIA 2120 ADVIA 120/2120 ADVIA Centaur Atellica CH Urea Nitrogen (UN_c) Atellica CH Uric Acid (UA) Atellica CH Iron_2 (Iron_2) Atellica CH Creatine Kinase (CK_L) Atellica CH Albumin (Alb) Atellica CH Aspartate Aminotransferase (AST) Atellica CH Inorganic Phosphorus (IP) Atellica CH Calcium (Ca) Atellica CH Vancomycin (Vanc) ADVIA Chemistry IP ADVIA Chemistry CREA ADVIA Chemistry UA ADVIA Chemistry CRE_2c ADVIA Chemistry AST_c ADVIA Chemistry UA_c ADVIA Chemistry AST ADVIA Chemistry UN ADVIA Chemistry CA_c ADVIA Chemistry CA ADVIA Chemistry IRON_2 ADVIA Chemistry IP_c ADVIA Chemistry AMY ADVIA Chemistry UN_c ADVIA Chemistry ALB ADVIA Chemistry MG ADVIA Chemistry MG_c ADVIA Chemistry P5P ADVIA Chemistry ALB_c ADVIA 120/2120 DCA Systems DCA Systems M/C Controls DCA Systems Microalbumin/Creatinine DCA Systems M/C Reagent Kit Atellica CH Amphetamines (AmpC) Atellica CH Amphetamines (Amp) Emit II Plus Amphetamine Assays ADVIA Chemistry TBIL_2 Atellica CH Total Bilirubin_2 (TBil_2) ADVIA Autoslide Module ADVIA Autoslide Slide Maker Stainer HEMA-TEK AUTOMATED HEM Atellica HEMA Slidemaker Stainer (SMS) ADVIA Autoslide System ADVIA Centaur Hepatitis A IgM (aHAVM) Atellica IM Hepatitis A IgM (aHAVM) Atellica IM Sample Inactivation Media ADVIA Chemistry Atellica IM NT proBNPII (PBNPII) ADVIA Centaur NT proBNPII (PBNPII) Atellica IM Cortisol (Cor) ADVIA Centaur Cortisol (Cor) ADVIA Centaur ADVIA Atellica IM 1600 Analyzer Atellica IM Cleaner Atellica IM Wash Atellica IM Acid/Base Atellica IM 1300 Analyzer Atellica IM Acid Atellica IM Ancillary Seal Kit Atellica IM Base Atellica IM 1300 Analyzer (Fully Refurbished) Atellica IM 1600 Analyzer (Fully Refurbished) ADVIA 120 248 BG System Total IgE IMMULITE 2000 Total IgE Atellica CH Theophylline (Theo) Dimension THEO Flex Dimension VALP Flex Atellica CH Valproic Acid (VPA) Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (aHBs2 QC) Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) ADVIA Centaur Anti-Hepatitis B surface Antigen 2 (aHBs2) ADVIA Centaur Anti-Hepatitis B surface Antigen 2 Quality Control KIT (aHBs2 QC) ADVIA Centaur Testosterone II Master Curve Material (TSTII MCM) Atellica IM Digoxin Master Curve Material (Dig MCM) IMMULITE PAP Control Module IMMULITE 2000 PAP (PAP) IMMULITE 2000 PAP IMMULITE 2000 Total Testosterone (TES) ADVIA ADVIA Chemistry ADVIA Centaur Hepatitis B Core Antigen (aHBcM) ADVIA Centaur Hepatitis Core Antigen Quality Control (aHBcM QC) Atellica IM Hepatitis Core Antigen Quality Control (aHBcM QC) Atellica IM Hepatitis B Core Antigen (aHBcM) Clinitek Status+ Clinitek Status CT Status CT Status+ IMMULITE 2000 TSIIMMULITE 2000 TSI Calibration Verification Material (TSI CVM) Atellica IM High-Sensitivity Troponin I (TnIH) ADVIA Centaur Enhanced Liver Fibrosis (ELF) Atellica IM Enhanced Liver Fibrosis (ELF) Atellica Sample Handler Prime (Fully Refurbished) Atellica Sample Handler Additional Atellica CH Reaction Cuvette Segment Atellica CH Dilution Cuvette Segment Atellica Tube Top Sample Cup Atellica Sample Handler Prime Atellica CH Amylase_2 (AMY_2) Dimension TOBR Flex Atellica CH Tobramycin (Tob) Atellica IM B-Type Natriuretic Peptide Quality Control (BNP QC) ADVIA Centaur BNP Calibrator (BNP CAL) Atellica IM BNP Calibrator (BNP CAL) Atellica IM B-type Natriuretic Peptide Master Curve Material (BNP MCM) ADVIA Centaur BNP 1,2,3 Quality Control (BNP QC) ADVIA Centaur BNP Master Curve Material (BNP MCM) ADVIA Centaur Homocysteine (HCY) Atellica IM Homocysteine (HCY) ADVIA Centaur Homocysteine Calibrator (HCY CAL) Atellica IM Homocysteine Calibrator (HCY CAL) ADVIA Centaur Homocysteine Diluent (HCY DIL) Atellica IM Homocysteine Diluent (HCY DIL) ADVIA Centaur Homocysteine Master Curve Material (HCY MCM) Atellica IM Vitamin D Total Quality Control (VitD QC) Atellica IM Vitamin D Total Master Curve Material (VitD MCM) ADVIA Centaur Hepatitis B Surface Antigen II (HBsII) Atellica IM Hepatitis B surface Antigen II Confirmatory (HBsII Conf) Atellica IM Hepatitis B Surface Antigen II (HBsII) Atellica IM Hepatitis B surface Antigen II Quality Control (HBsII QC) ADVIA Chemistry Enzyme 2 Calibrator (ENZ 2 CAL) ADVIA Chemistry ADVIA Chemistry Enzyme 1 Calibrator (ENZ 1 CAL) Atellica CH ENZ 1 Calibrator (ENZ 1 CAL) Atellica CH ENZ 2 Calibrator (ENZ 2 CAL) ADVIA Chemistry Enzyme 3 Calibrator (ENZ 3 CAL) ADVIA Chemistry Atellica CH Alanine Aminotransferase (ALT) Dimension Vista ALTI Flex Dimension ALTI Flex Atellica CH Alanine Aminotransferase P5P (ALTPLc) RapidQC Hct ADVIA Centaur IMMULITE 2000 Cherry F242 IMMULITE 2000 Lamb F88 IMMULITE 2000 Trout F204 IMMULITE 2000 Turkey Meat F284 IMMULITE 2000 Chestnut F299 IMMULITE 2000 Cabbage F216 IMMULITE 2000 Pineapple F210 IMMULITE 2000 Lemon F208 IMMULITE 2000 Grapefruit F209 IMMULITE 2000 Watermelon F329 IMMULITE 2000 Pumpkin F225 IMMULITE 2000 Cheese, Mold Type F82 IMMULITE 2000 Spinach F214 IMMULITE 2000 Cucumber F244 IMMULITE 2000 Pear F94 IMMULITE 2000 Plum F255 IMMULITE 2000 Peach F95 IMMULITE 2000 Sweet Potato F54 IMMULITE 2000 Coffee F221 IMMULITE 2000 Grape F259 IMMULITE 2000 Sole F337 IMMULITE 2000 Chocolate F105 IMMULITE 2000 Broccoli F260 IMMULITE 2000 Red Snapper F381 IMMULITE 2000 Haddock F42 IMMULITE 2000 Lima Bean F182 IMMULITE 2000 Black Pepper F280 IMMULITE 2000 Avocado F96 ADVIA Centaur IL6 Quality Control Material (IL6 QC) ADVIA Centaur IL6 Assay (IL6) Atellica IM IL6 Quality Control Material (IL6 QC) Atellica IM IL6 Assay (IL6) JGS - ELECTRODE, ION SPECIFIC, SODIUM JFP - ELECTRODE, ION SPECIFIC, CALCIUM CGZ - ELECTRODE, ION-SPECIFIC, CHLORIDE Emit 2000 Tobramycin Calibrators Emit 2000 Tobramycin Assay ADVIA Chemistry D-HDL Reagent ADVIA 360/560 Hematology System ADVIA 360 Cleaner ADVIA 360 Lyse 3P Diff ADVIA 360, 560 Hypoclean Atellica CH Fructosamine (Fruc) Atellica CH Fructosamine Calibrator Atellica IM Cyclosporine Master Curve Material (CsA MCM) ADVIA Centaur Cyclosporine Master Curve Material (CsA MCM) Vista LA Flex Atellica CH Lac_3 Atellica HEMA Baso (HEMA Baso) Atellica HEMA Diff (HEMA Diff) Atellica HEMA HGB (HEMA HGB) RAPIDPoint® 500e Blood Gas System iCa++ Quick Sampler ADVIA Centaur ADVIA 60 ADVIA Centaur B-type Natriuretic Peptide (BNP) Atellica IM B-type Natriuretic Peptide (BNP) ADVIA Centaur Myoglobin (MYO) Atellica IM Myoglobin (MYO) ADVIA Centaur Calibrator U (Cal U) Atellica IM Calibrator U (Cal U) ADVIA Centaur Myoglobin Master Curve Material (MYO MCM) Emit 2000 Vancomycin Assay Dimension PHNO Flex Atellica CH Phenobarbital (Phnb) Dimension Vista A1AT Flex Atellica CH Alpha-1-Antitrypsin 2 (AAT2) RapidQC CVM ADVIA 120 ADVIA Centaur ADVIA Chemistry Emit II Plus Ethyl Alcohol Assays ADVIA ADVIA IMMULITE 2000 Folic Acid (FOL) IMMULITE 2000 Folic Acid /Vitamin B12 Sample Diluent IMMULITE Ascorbic Acid (Ascorbic Acid) Atellica CH Cocaine Metabolite (Coc) Atellica CH Cocaine Metabolite (CocC) ULTRA II MONO AND DUO AUTOMATED TISSUE AUTOTECHNICON ULTRA Atellica HEMA Cleaner (HEMA Cleaner) Atellica HEMA Decon (HEMA Decon) Atellica CH Cholinesterase_2 (CHE_2) POCcelerator UniPOC CentraLink RAPIDComm Atellica Data Manager (ADM) Atellica® Connect SE Atellica® Connect EDM eDM Lite Emit II Plus Phencyclidine Assays Dimension Vista Lipase Flex ADVIA Chemistry Lipase Dimension Lipase Flex Atellica IM Creatine Kinase MB (CKMB) ADVIA Centaur Creatine Kinase MB Calibrator (CKMB CAL) Atellica IM Creatine Kinase MB Master Curve Material (CKMB MCM) ADVIA Centaur Creatine Kinase MB Diluent (CKMB Dil) Atellica IM Creatine Kinase MB Diluent (CKMB Dil) ADVIA Centaur Creatine Kinase MB (CKMB) Atellica IM Creatine Kinase MB Calibrator (CKMB CAL) ADVIA Centaur Creatine Kinase MB Master Curve Material (CKMB MCM) CS-2500 ADVIA Centaur DHEA-SO4 (DHEAS) Atellica IM DHEA-SO4 (DHEAS) Atellica IM DHEAS2 (DHEAS2) ADVIA ADVIA Chemistry Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) Atellica Rack Handler Atellica CI Reaction Cuvette Segments Atellica CI Dilution Cuvette Segments Atellica CI Analyzer; (Model 1900) Atellica CH Albumin BCP (AlbP) Atellica Direct Connect for CI IMMULITE 2000 Blomia Tropicalis D20, 20 size IMMULITE 2000 Chicken Feathers E85, 20 size IMMULITE 2000 nDer p1 A310, 20 Size IMMULITE 2000 Brazilian Peppertree T401, 20 size IMMULITE 2000 nDer f2 A302, 20 size IMMULITE 2000 Penicillium Brevi-Compactum M305, 20 size IMMULITE 2000 nCan f 1 A174, 20 size IMMULITE 2000 nPen m 1, F351, 20 size IMMULITE 2000 Rabbit Bush W36, 20 size IMMULITE 2000 Turkey Feathers E89, 20 size IMMULITE 2000 Parrot Feathers E91, 20 size IMMULITE 2000 Pigeon Droppings E7, 20 size IMMULITE 2000 nDer f 1 A295, 20 size IMMULITE 2000 Aureobasidium Pullulans M12, 20 size IMMULITE 2000 nFel d 1 A345, 20 size IMMULITE 2000 nAsp r 1 A3050, 20 size IMMULITE 2000 Tobacco O201, 20 size IMMULITE 2000 Canary feather E201, 20 size IMMULITE 2000 Loblolly Pine T43, 20 size IMMULITE 2000 Budgerigar Feathers E78, 20 size IMMULITE 2000 nDer p 2 A316, 20 size Atellica CH Barbiturates (BrbC) Atellica CH Brb Atellica IM Ferritin Assay ADVIA ADVIA Centaur Atellica IM Testosterone II Master Curve Material (TSTII MCM) ADVIA Centaur Sex Hormone Binding Globulin 2 Master Curve Material MCM (SHBG2) ADVIA Centaur Sex Hormone Binding Globulin (SHBG) Atellica IM Sex Hormone Binding Globulin Calibrator (SHBG CAL) ADVIA Centaur Sex Hormone Binding Globulin Calibrator (SHBG CAL) Atellica IM Sex Hormone Binding Globulin Master Curve Material (SHBG MCM) Atellica IM Follicle Stimulating Hormone (FSH) ADVIA Centaur Follicle Stimulating Hormone (FSH) IMMULITE 2000 DHEA-SO4 (DHS) ADVIA Centaur CA 19-9 (CA 19-9) Atellica IM CA 19-9 (CA 19-9) Atellica IM CA 19-9 Diluent (CA 19-9 DIL) ADVIA Centaur CA 19-9 Diluent (CA 19-9 DIL) Atellica IM CA 19-9 Master Curve Material (CA 19-9 MCM) ADVIA Centaur CA 19-9 Master Curve Material (CA 19-9 MCM) IMMULITE Vitamin B12 IMMULITE 2000 VITAMIN B12 BAYER ADVIA 1650 APOLI VANC Calibrator IMMULITE 2000 Mixed Allergen Panels Clinitek Novus Positive Control Strips Atlas Negative Control Clinitek Atlas 12 Atlas Cal Kit Atlas Clarity Calibrator Atlas Positive Control Clinitek Atlas CLINITEK Atlas Carosel Clinitek Family CLINITEK Atlas Rack Clinitek Atlas 10 Clinitek Novus Negative Control Strips ADVIA Centaur Insulin Assay (IRI) ADVIA Centaur Insulin Diluent (IRI Dil) Atellica IM Insulin Assay (IRI) Atellica IM Insulin Diluent (IRI Dil) Dimension Vista sALB Flex reagent cartridge (sALB) Atellica CH Urine Albumin (UAlb) Atellica CH Ecstasy (XtcC) Emit II Plus Ecstasy Assay Atellica CH Ecstasy (Xtc) BCS XP System BCS System Cuvette Rotors BC Vial Kit LA 2 Confirmation Reagent LA 1 Screening Reagent IMMULITE 2000 Specific Allergens IMMULITE 2000 3gAllergy Specific IgE Clinistix Kidney Health Test Kit ADVIA Chemistry DLDL ADVIA Chemistry PAmy ADVIA Centaur Complexed Prostate-specific Antigen (cPSA) ADVIA Centaur Complexed Prostate-specific Antigen Pretreatment Reagent (cPSA Pre) Atellica IM Complexed Prostate-specific Antigen (cPSA) ADVIA Centaur Complexed Prostate-specific Antigen Quality Control (cPSA QC) Atellica IM Complexed Prostate-specific Antigen Pretreatment Reagent (cPSA Pre) Atellica IM Complexed Prostate-specific Antigen Quality Control (cPSA QC) ADVIA Centaur Complexed Prostate-Specific Antigen Master Curve Material (cPSA MCM) Atellica IM Calibrator Y (CAL Y) ADVIA Centaur Calibrator Y (CAL Y) Atellica CH Prealbumin (PreAlb) ADVIA ADVIA Chemistry ADVIA Chemistry Atellica HEMA Calibrator BFT II Analyzer "Dispo System" Cuvettes for BFT II Analyzer BFT II Analyzer Printer Paper for BFT II ADVIA Chemistry Atellica HEMA Retic Control (L) Atellica HEMA Retic Control (H) Atellica HEMA Control BF (H) Atellica HEMA Retic Control (N) Atellica HEMA Control (L) Atellica HEMA Control (N) Atellica HEMA Control (H) Atellica HEMA Control BF (N) ADVIA Chemistry ADVIA Centaur Intact PTH Master Curve Material (iPTH MCM) Atellica IM BRAHMS Procalcitonin (PCT) ADVIA Centaur IgE Master Curve Material (IgE MCM) Atellica CH Cholesterol_2 (Chol_2) ADVIA Centaur BR Assay (BR) Atellica IM BR 27.29 (BR) IMMULITE® 2000 3gAllergyTM Specific IgE Universal Kit rMal d 4, (A796 Apple, Malus domestica) rBet v 2, (A127 Birch pollen, Betula verrucose) rPru av 1, (A597 Cherry, Prunus avium) rPru av 3, (A599 Cherry, Prunus avium) rPru av 4 (A600 Cherry, Prunus avium) n Pru p 3, (A603 Peach, Prunus persica) rMal d 1 (A464 Apple, Malus domestica) ADVIA Centaur Cortisol Master Curve Material (Cor MCM) ADVIA Centaur Cortisol Urine Reconstitution Buffer (COR Recon Buf) Atellica IM Cortisol Urine Reconstitution Buffer (COR Recon Buf) Atellica CH Apolipoprotein A-1 & B Calibrator (APO A1 & B CAL) ADVIA Chemistry Apolipoprotein A-1/B Calibrator (APO A1 B Cal) Multicap Blood Collection Capillaries Capillary Caps Luer Capillary Blood Gas Blood Collection Capillary Tubes Plastic Capillaries ADVIA Chemistry Atellica CH Digoxin (Dgn) BAYER ADVIA 1650 MIC ADVIA Centaur Atellica IM IMMULITE IMMULITE 2000 Erythropoietin (EPO) IMMULITE/IMMULITE 1000 Erythropoietin (EPO) Sample Diluent IMMULITE EPO IMMULITE EPO Control Module Emit II Plus Opiate Assays Atellica CH Opiates (Op) Atellica CH Opiates (OpC) Dimension LIDO Flex Atellica CH LIDO Assay Atellica IM Insulin Master Curve Material (IRI MCM) Atellica IM Insulin Calibrator (IRI Cal) ADVIA Centaur Insulin Master Curve Material (IRI MCM) ADVIA Centaur TSH3-Ultra II (TSH3ULII) Atellica IM CA 125II Master Curve Material (CA 125II MCM) Atellica IM CA 125II Calibrator (CA 125II CAL) ADVIA Centaur CA 125II Calibrator (CA 125II CAL) ADVIA Centaur CA 125II Master Curve Material (CA 125II MCM) Atellica IM Anti-Mullerian Hormone (AMH) Atellica IM AMH Quality Control (AMH QC) Atellica IM AMH Master Curve Material (AMH MCM) ADVIA Centaur AMH Quality Control (AMH QC) ADVIA Centaur Anti-Mullerian Hormone (AMH) ADVIA Centaur AMH Master Curve Material (AMH MCM) ADVIA Centaur Vitamin D Total Master Curve Material (VitD MCM) ADVIA Centaur Vitamin D Total Diluent Quality Control (VitD QC) ADVIA Centaur Vitamin D Total Diluent (VitD DIL) IMMULITE 2000 Carcinoembryonic Antigen (CEA) ADVIA Centaur Atellica IM ADVIA Centaur Atellica IM Rubella IgM Quality Control (Rub M QC) Atellica IM Rubella IgM (Rub M) Atellica CH Creatinine_2 (Crea_2) ADVIA Centaur Calcitonin (CALCT) assay Atellica IM Calcitonin (CALCT) assay Emit 2000 Tacrolimus Sample Pretrea Atellica CH Tacrolimus Emit 2000 Tacrolimus Assay Dimension PTN Flex Atellica CH Phenytoin (Phny) ADVIA Chemistry Atellica CH Complement C4 (C4) ADVIA ADVIA Centaur Analyzer, ADVIA Centaur Classic IMMULITE 2000 BR-MA Atellica CH Revised C-Reactive Protein Assay (RCRP) Dimension RCRP Flex ADVIA Centaur ThCG ADVIA Centaur ThCG Diluent IMMULITE 1000 Sycamore T11 (T11) IMMULITE 2000 L2SNC Specific IgE Negative Control IMMULITE 2000 3gAllergy Specific IgE (SPE) IMMULITE 2000 DC2L Specific IgE Positive Control IMMULITE 2000 Specific Allergens IMMULITE 2000 MC6L Specific IgE Positive Control IMMULITE 2000 DC1L Specific IgE Positive Control ADVIA Chemistry IMMULITE Gastrin Control Module (GAS QC) IMMULITE IgF Control Module (IGF QC) ADVIA 1650 CHOLESTEROL TEST SYSTEM ADVIA Centaur TECHNICON RA-1000 SYSTEM ADVIA 120/2120 CLINITEK Family (500, 200, 100) CLINITEK Advantus ADVIA Chemistry HDL/LDL Cholesterol Calibrator ADVIA ADVIA Chemistry ALP_2 Calibrator Atellica CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL) Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c) Dimension ALPI Calibrator Dimension ALPI Flex ADVIA Centaur ADVIA Chemistry Atellica CH Gamma-Glutamyl Transferase (GGT) ADVIA ADVIA Chemistry Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC) ADVIA Centaur Hepatitis B e Antigen Quality Control (HBeAg QC) Atellica IM Hepatitis B e Antigen (HBeAg) ADVIA Centaur Hepatitis B e Antigen (HBeAg) ADVIA Chemistry ADVIA Chemistry ADVIA Centaur Alpha Fetoprotein Master Curve Material (AFP MCM) ADVIA Centaur AFP Atellica IM Alpha Fetoprotein (AFP) Atellica IM Alpha Fetoprotein Master Curve Material SET (AFP MCM) ADVIA Centaur Progesterone Master Curve Material (PRGE MCM) Atellica IM Ferritin Master Curve Material (FER MCM) Atellica IM Progesterone Master Curve Material (PRGE MCM) ADVIA Centaur Ferritin Master Curve Material (FER MCM) Oregano (F283), Parsley (F86), Pine Nut (F253), Vanilla (F234) 3gAllergy Specific Allergens: Basil (F269), Cacao (F93), IMMULITE 2000 Anti-CCP Calibration Verification Material (CCP CVM) IMMULITE 2000 Anti-CCP IgG (CCP) ADVIA Chemistry Atellica CH CO2 Calibrator/Diluent (CO2 CAL) ADVIA IMMULITE Thyroid Control Module ADVIA Hematology ADVIA 360 / 560 Calibrator ADVIA Centaur Prolactin Master Curve Material (PRL MCM) Atellica IM Prolactin Master Curve Material (PRL MCM) ADIVA CENTAUR CP ANALYZER BCS XP System BC Validation Kit Atellica CH Protein 1 Calibrator (PROT1 CAL) Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL) Atellica CH Bilirubin Calibrator (BILI CAL) Urin-Tek, Urine Collection System RAPIDChem® 700 Urine Diluent ADVIA ADVIA Chemistry ADVIA Chemistry Atellica HEMA RET/PLTO (HEMA RET/PLTO) GAS, CALIBRATION (SPECIFIED CONCENTRATION (Cal Gas) ADVIA Centaur Tumor Marker Quality Control (TMQC) Atellica IM EPO Controls (EPO QC) ADVIA Centaur Calcitonin MCM (CALCT MCM) Atellica IM Androstenedione MCM (ANDRO MCM) Atellica IM Tumor Marker Quality Control (TMQC) Atellica IM Enhanced Liver Fibrosis Master Curve Material (ELF MCM) Atellica IM Active-B12 Master Curve Material (AB12 MCM) Atellica IM PBNPII Master Curve Material (PBNPII MCM) Atellica IM Active-B12 QC (AB12 QC) Atellica IM PSA MCM (PSA MCM) ADVIA Centaur Androstenedione (ANDRO) Master Curve Material (ANDRO MCM) Atellica IM B.R.A.H.M.S PCT MCM (PCT MCM) ADVIA Centaur Insulin Master Curve Material (IRI MCM) ADVIA Centaur aCCP Control (aCCP QC) Atellica IM Anti-HBe2 Quality Control (aHBe2 QC) ADVIA Centaur Anti-HBe2 Quality Control (aHBe2 QC) Atellica IM B.R.A.H.M.S PCT QC (PCT QC) Atellica IM Anti-CCP IgG Quality Control (aCCP QC) Atellica IM Anti-CCP IgG Master Curve Material (aCCP MCM) Atellica IM Cytokeratin Fragment 21-1 MCM (CYFRA MCM) ADVIA Centaur Active-B12 Quality Control (AB12 QC) ADVIA Centaur aCCP MCM (aCCP MCM) ADVIA Centaur Anti-Hepatitis B surface Antigen 2 Master Curve Material Set (aHBs2 MCM) ADVIA Centaur Herpes-2 IgG Quality Control (HSV2 QC) ADVIA Centaur Enhanced Liver Fibrosis Quality Control (ELF QC) Atellica IM DHEAS2 Master Curve Material (DHEAS2 MCM) Atellica IM EPO MCM (EPO MCM) Atellica IM Anti-Hepatitis B surface Antigen 2 Master Curve Material Set (aHBs2 MCM) ADVIA Centaur Enhanced Liver Fibrosis Master Curve Material (ELF MCM) Atellica IM Calcitonin MCM (CALCT MCM) ADVIA Centaur PBNPII Master Curve Material (PBNPII MCM) ADVIA Centaur Active-B12 Master Curve Material (AB12 MCM) Atellica IM Enhanced Liver Fibrosis Quality Control (ELF QC) Atellica IM fPSAII Master Curve Material (tPSAII MCM) Atellica IM High Sensitivity Troponin I Master Curve Material (TnIH MCM) ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) ADVIA Centaur EPO MCM (EPO MCM) Atellica IM Luteinizing Hormone Master Curve Material (LH MCM) ADVIA Centaur Prostate-Specific Antigen Master Curve Material (PSA MCM) ADVIA Centaur EPO QC (EPO QC) IMMULITE CMV IgG Control Module IMMULITE IMMULITE CMV IgG IMMULITE CMV IgG Control Module (CVG QC) ADVIA Centaur Free Triiodothyronine (FT3) Atellica IM Free Triiodothyronine (FT3) ADVIA Centaur Free Triiodothyronine Master Curve Material (FT3 MCM) Dimension PROC Flex Atellica CH Procainamide (PROC) Atellica CH Carbon Dioxide, Concentrated (CO2_c) ADVIA ADVIA Chemistry Vista FSH Flex IMMULITE® 2000 FSH IMMULITE® 2000 FSH Sample Diluent IMMULITE® / IMMULITE® 1000 FSH Atellica CH Iron3 (Iron_3) ADVIA Chemistry IMMULITE IMMULITE 2000 Anti-TG Ab Anti-thyroglobulin antibody ADVIA Centaur Atellica IM Calibrator 30 (CAL 30) ADVIA ADVIA Centaur Prolactin (PRL) Atellica IM Prolactin (PRL) Dimension AMM Flex Atellica CH Ammonia (Amm) ADVIA Chemistry ADVIA Dimension Drugs of Abuse Pos Ctrl ADVIA® Chemistry Toxicology Controls Dimension Drugs of Abuse Neg Ctrl ADVIA Centaur XPT Cytokeratin Fragment 21-1 (CYFRA) Atellica IM Cytokeratin Fragment 21-1 (CYFRA) Atellica IM Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL) ADVIA Centaur XPT Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL) Atellica CH C-Reactive Protein_2 Calibrators (CRP_2 CAL) Atellica CH C-Reactive Protein_2 (CRP_2) ADVIA ADVIA Chemistry ADVIA Centaur Herpes-1 IgG (HSV1) Atellica IM Herpes-1 IgG (HSV1) ADVIA Chemistry Atellica CH Lipoprotein(a) (Lp(a)) Atellica CH Lipoprotein(a) Calibrator (Lp(a) CAL) CLINITEK Novus 10 Urinalysis Cassette CLINITEK Novus Calibration Kit CLINITEK Novus Automated Urine Chemistry Analyzer ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) Atellica CH Cystatin C_2 Assay (CYSC_2)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2021-07-19
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2021-07-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2016-09-22
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2016-09-22
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2008-01-02
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-01-02
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-01-02
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2008-01-02
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2008-01-02
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2008-01-02
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2008-01-02
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2008-01-02
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-01-02
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2008-01-02
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2008-01-02
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2008-01-02
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2008-01-02
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2008-01-02
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2008-01-02
LGS Fluorescence Polarization Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2008-01-02
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2008-01-02
LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) Clinical Toxicology Class 2 862.3350 2008-01-02
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2008-01-02
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2008-01-02
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-01-02
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2008-01-02
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2008-01-02
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2008-01-02
LCR Fluorescent Immunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2008-01-02
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2008-01-02
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2008-01-02
LCD Enzyme Immunoassay, Gentamicin Clinical Toxicology Class 2 862.3450 2008-01-02
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2008-01-02
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2015-07-01
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 1995-04-18
LOL Hepatitis A Test (Antibody And Igm Antibody) Microbiology Class 2 866.3310 2007-12-27
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2008-01-07
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2011-06-28
MKW Cyclosporine Clinical Chemistry Class 2 862.1235 2011-06-28
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 1998-06-16
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2025-12-12
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2025-12-12
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2025-12-12
JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin Immunology Class 2 866.5340 2003-03-03
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2010-12-09
MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions Unknown Class 3 N/A 2008-09-22
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2009-05-28
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2011-07-28
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2008-01-09
JZW Nephelometer Immunology Class 1 866.4540 2007-11-14
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2007-11-27
JJC Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use Clinical Chemistry Class 1 862.2150 1998-02-19
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2011-06-28
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2008-01-07
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2023-08-11
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2023-08-11
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-06-29
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2025-12-15
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2008-01-10
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2025-12-15
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2007-12-27
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 1998-02-24
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2017-05-25
KRZ Calibrator For Hemoglobin And Hematocrit Measurement Hematology Class 2 864.8165 2013-01-28
DKJ Colorimetry, Salicylate Clinical Toxicology Class 2 862.3830 2010-06-08
CIZ Radioimmunoassay, Androstenedione Clinical Chemistry Class 1 862.1075 2006-08-04
QFO Zika Virus Serological Reagents Microbiology Class 2 866.3935 2019-09-12
QCH Assayed Quality Control Material For Clinical Microbiology Assays Microbiology Class 2 866.3920 2019-09-12
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2018-02-02
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2008-01-07
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2013-01-28
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2012-07-26
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Immunology Class 2 866.5775 2016-08-11
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2007-12-28
JHN Turbidimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 2002-05-07
GTQ Antistreptolysin - Titer/Streptolysin O Reagent Microbiology Class 1 866.3720 2003-07-15
JFT Fluorometric, Cortisol Clinical Chemistry Class 2 862.1205 2011-06-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-06-29
JHN Turbidimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 2011-07-28
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2026-01-06
JNL Immunochemical, Thyroglobulin Autoantibody Immunology Class 2 866.5870 2026-01-06
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2026-01-06
CKG Radioimmunoassay, Acth Clinical Chemistry Class 2 862.1025 2003-03-03
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2008-01-07
JRI Cuvette, Thermostated Clinical Chemistry Class 1 862.2050 1998-02-12
MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions Unknown Class 3 N/A 2007-12-28
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2007-12-28
MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer Unknown Class 3 N/A 2007-12-28
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-06-28
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2025-01-15
GIF Diluent, Blood Cell Hematology Class 1 864.8200 1998-02-12
QCH Assayed Quality Control Material For Clinical Microbiology Assays Microbiology Class 2 866.3920 2018-08-07
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2018-08-07
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2012-01-30
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2012-01-30
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2023-06-30
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2009-12-09
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2011-06-28
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-06-28
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2026-06-12
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2026-06-12
LAN Enzyme Immunoassay, N-Acetylprocainamide Clinical Toxicology Class 2 862.3320 2007-11-15
JZJ Prealbumin, Antigen, Antiserum, Control Immunology Class 1 866.5060 2003-01-16
MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer Unknown Class 3 N/A 2026-03-06
NDW Assay, Porphyrin, Spectrophotometry, Lithium Clinical Toxicology Class 2 862.3560 2008-01-09
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-01-09
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-01-09
KLT Enzyme Immunoassay, Carbamazepine Clinical Toxicology Class 2 862.3645 2007-11-19
JMO Ferrozine (Colorimetric) Iron Binding Capacity Clinical Chemistry Class 1 862.1415 2008-01-09
JHR Radioimmunoassay, Immunoglobulins (D, E) Immunology Class 2 866.5510 2009-12-10
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-06-28
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2019-07-02
MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions Unknown Class 3 N/A 2026-05-29
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2012-12-04
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer Immunology Class 2 866.6010 2007-12-27
MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Microbiology Class 2 866.3169 2007-12-27
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2008-01-09
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2001-08-18
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-12-27
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2007-12-27
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2007-12-27
JCB Detergent Pathology Class 1 864.4010 2007-12-04
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2007-11-27
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2007-11-27
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2008-01-09
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-06-28
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2011-06-28
DHX System, Test, Carcinoembryonic Antigen Immunology Class 2 866.6010 2007-12-27
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2015-04-27
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2015-04-27
LKL Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control Immunology Class 1 866.5420 2007-12-02
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Microbiology Class 2 866.3305 2005-05-12
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2025-12-15
JNM Immunochemical, Transferrin Immunology Class 2 866.5880 2008-01-07
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2008-01-07
MSJ Apolipoproteins Clinical Chemistry Class 1 862.1475 2008-01-07
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2008-01-07
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2008-01-07
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2010-12-20
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2010-12-20
LKQ Antibody Igm,If, Cytomegalovirus Virus Microbiology Class 2 866.3175 2010-12-20
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2010-04-29
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-01-07
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-01-07
CKB Acid Phosphatase, Naphthyl Phosphate Clinical Chemistry Class 2 862.1020 2008-01-07
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2018-05-16
DIP Enzyme Immunoassay, Diphenylhydantoin Clinical Toxicology Class 2 862.3350 2007-11-19
NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2010-03-19
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2010-03-19
CJY Azo Dye, Calcium Clinical Chemistry Class 2 862.1145 2010-04-27
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2010-08-11
JHX Fluorometric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2008-01-09
KLT Enzyme Immunoassay, Carbamazepine Clinical Toxicology Class 2 862.3645 2007-11-27
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2015-04-02
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2015-04-02
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2009-05-07
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2006-09-27
CAN Regulator, Pressure, Gas Cylinder Anesthesiology Class 1 868.2700 2020-07-02
CJW Bromcresol Purple Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2013-12-12
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2013-12-12
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 2002-05-07
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-08-04
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-06-28
JPZ Colorimetric Method, Gamma-Glutamyl Transpeptidase Clinical Chemistry Class 1 862.1360 2002-05-07
JCN Control, Cell Counter, Normal And Abnormal Hematology Class 2 864.8625 2013-01-28
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2008-01-09
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2012-08-02
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2008-01-07
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2007-12-27
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2005-05-12
JKR Radioimmunoassay, Calcitonin Clinical Chemistry Class 2 862.1140 2005-05-12
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2009-07-02
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2018-05-29
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-08-28
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2025-02-27
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2005-05-12
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2007-12-28
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2007-11-15
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2007-12-28
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2007-12-28
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2005-04-27
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2019-05-20
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2013-03-27
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2007-12-05
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2007-12-27
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2018-01-25
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2018-01-25
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2014-01-14
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2017-05-16
CJW Bromcresol Purple Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2017-05-16
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2017-05-16
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2017-05-16
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-05-16
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2017-05-16
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2017-05-16
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2007-12-27
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2022-01-11
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2007-12-27
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2007-12-27
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2008-01-18
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2008-01-18
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2008-01-18
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2023-08-02
JKD Radioimmunoassay, C-Peptides Of Proinsulin Clinical Chemistry Class 1 862.1135 2002-08-13
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2017-08-01
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2008-01-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-03-20
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2007-12-28
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2022-01-11
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2022-01-11
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2010-08-23
JLB Atp And Creatine Kinase (Enzymatic), Creatine Clinical Chemistry Class 1 862.1210 2002-05-07
KSX Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use Hematology Class 2 864.9160 2021-12-17
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2007-12-28
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-08-31
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2026-02-17
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2007-12-28
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2007-12-28
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2015-05-07
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2008-09-18
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2007-11-15
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2015-05-07
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2005-05-12
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2016-08-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-08-08
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2008-01-07
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2008-01-07
GKL Counter, Cell, Automated (Particle Counter) Hematology Class 2 864.5200 2008-01-07
LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) Clinical Toxicology Class 2 862.3350 2007-12-27
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2008-01-07
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2008-01-07
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2008-01-07
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2008-01-07
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2008-01-07
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2008-01-07
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2008-01-07
KHM Nephelometric, Amylase Clinical Chemistry Class 2 862.1070 2008-01-07
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2008-01-07
CJK Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2008-01-07
CFO Titrimetric, Magnesium Clinical Chemistry Class 1 862.1495 2008-01-07
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2008-01-07
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2008-01-07
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2008-01-07
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2008-01-07
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2008-01-07
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2008-01-07
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2012-08-02
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2008-01-18
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2007-11-15
JFM Enzymatic Method, Bilirubin Clinical Chemistry Class 2 862.1110 2008-01-10
KPA Slide Stainer, Automated Pathology Class 1 864.3800 1977-12-31
LOL Hepatitis A Test (Antibody And Igm Antibody) Microbiology Class 2 866.3310 2025-12-15
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2021-05-25
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2008-01-09
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2024-01-25
JFT Fluorometric, Cortisol Clinical Chemistry Class 2 862.1205 2025-12-15
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2011-06-29
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-06-29
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2017-06-16
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2017-06-16
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-06-16
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2008-01-07
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2010-02-02
JHR Radioimmunoassay, Immunoglobulins (D, E) Immunology Class 2 866.5510 2011-03-25
DLZ Enzyme Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2011-09-22
DIP Enzyme Immunoassay, Diphenylhydantoin Clinical Toxicology Class 2 862.3350 2011-09-22
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2011-09-22
LEG Enzyme Immunoassay, Valproic Acid Clinical Toxicology Class 2 862.3645 2007-11-27
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2012-11-28
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2012-11-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-04-11
JFH Acid Phosphatase (Prostatic), Tartrate Inhibited Clinical Chemistry Class 2 862.1020 2003-03-03
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2003-03-03
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2011-06-28
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2007-12-27
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2007-12-27
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2010-01-26
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2010-01-26
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2010-01-26
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2010-01-26
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2010-01-26
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2010-01-26
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2010-01-26
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2010-01-26
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2010-01-26
JIP Blood, Occult, Enzymatic Method, In Urine Hematology Class 2 864.6550 2010-01-26
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2010-01-26
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2010-01-26
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2010-01-26
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2016-03-03
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2024-08-28
QQB Prognostic Test For Assessment Of Liver Related Disease Progression Clinical Chemistry Class 2 862.1622 2021-09-17
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2017-05-04
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2017-05-04
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2017-05-04
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2017-05-04
CJW Bromcresol Purple Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2017-05-04
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2017-05-04
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2017-05-04
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2019-08-08
LCR Fluorescent Immunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2007-11-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-06-29
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2011-06-29
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2011-06-29
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2007-12-27
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2007-12-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-08-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2014-08-11
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2014-08-11
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2014-05-20
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2016-02-09
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2002-05-07
GLK Control, Hematocrit Hematology Class 2 864.8625 2010-02-05
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2007-12-28
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2009-11-05
QLC Interleukin 6 Unknown Class N N/A 2021-01-07
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2018-02-02
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2018-02-02
GKF Instrument, Hematocrit, Automated Hematology Class 2 864.5600 2018-02-02
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2018-02-02
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2018-02-02
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2018-02-02
KLB Radioimmunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2007-11-14
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2007-11-14
LDO Enzymatic Radiochemical Assay, Tobramycin Clinical Toxicology Class 2 862.3900 2007-11-14
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2011-06-28
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2015-04-27
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2014-02-11
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2014-02-11
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-06-28
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2006-08-01
GGK Products, Red-Cell Lysing Products Hematology Class 1 864.8540 2025-12-15
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2020-03-30
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2020-03-30
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2020-03-30
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2020-03-30
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2020-03-30
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2020-03-30
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2020-03-30
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2020-03-30
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2020-03-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2007-12-28
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2008-01-07
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2025-12-15
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2007-12-27
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2007-11-15
DLZ Enzyme Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2007-11-24
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control Immunology Class 2 866.5130 2007-12-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2007-12-04
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2007-12-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2010-01-27
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2011-04-11
GKL Counter, Cell, Automated (Particle Counter) Hematology Class 2 864.5200 2011-04-11
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2008-01-03
DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method Clinical Toxicology Class 2 862.3040 2007-11-27
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2011-06-28
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-06-28
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2005-05-12
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2007-11-15
IEO Processor, Tissue, Automated Pathology Class 1 864.3875 1977-12-20
PPM General Purpose Reagent Pathology Class 1 864.4010 1998-02-19
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2022-05-09
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2000-02-07
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2007-11-27
CHI Lipase-Esterase, Enzymatic, Photometric, Lipase Clinical Chemistry Class 1 862.1465 2007-11-14
JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2007-12-27
JHX Fluorometric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2007-12-27
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2017-02-03
JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) Clinical Chemistry Class 1 862.1245 2013-02-06
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-08-23
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2011-08-23
CJW Bromcresol Purple Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2023-07-20
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2023-07-20
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2023-07-20
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2011-04-04
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2007-11-15
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2017-09-14
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2011-06-28
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2016-07-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-07-21
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2016-07-21
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2007-12-27
JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) Clinical Chemistry Class 1 862.1245 2005-05-17
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2007-12-27
NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer Immunology Class 2 866.6010 2007-12-27
LIG Radioassay, Intrinsic Factor Blocking Antibody Clinical Chemistry Class 2 862.1810 2006-08-04
MSJ Apolipoproteins Clinical Chemistry Class 1 862.1475 2002-05-07
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2012-08-02
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2009-05-28
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2008-03-13
CFP Radioimmunoassay, Immunoreactive Insulin Clinical Chemistry Class 1 862.1405 2002-08-13
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2004-07-14
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2007-11-15
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2007-11-15
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2007-11-15
GIR Reagent, Russel Viper Venom Hematology Class 1 864.8950 2007-12-04
GGP Test, Qualitative And Quantitative Factor Deficiency Hematology Class 2 864.7290 2007-12-04
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2007-12-04
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2009-06-11
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2023-01-13
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2023-01-13
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2011-06-28
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2010-04-27
NAF Antigen(Complexed),Prostate Specific,(Cpsa) Unknown Class 3 N/A 2007-12-27
JZJ Prealbumin, Antigen, Antiserum, Control Immunology Class 1 866.5060 2011-06-28
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2008-01-09
KSA Calibrator For Red-Cell And White-Cell Counting Hematology Class 2 864.8185 2021-12-17
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2007-12-05
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2008-01-07
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2021-12-15
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2008-01-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-12-27
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2007-12-27
PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens Microbiology Class 2 866.3215 2018-07-18
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-03-20
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2017-05-16
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2025-12-15
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2022-07-18
JFT Fluorometric, Cortisol Clinical Chemistry Class 2 862.1205 2006-09-27
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-06-29
GIO Tube, Collection, Capillary Blood Hematology Class 1 864.6150 2001-11-15
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2008-01-09
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2008-01-07
DDZ Albumin, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5040 2002-05-07
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2012-02-03
GGT Assay, Erythropoietin Hematology Class 2 864.7250 2005-05-12
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2007-11-27
KLR Enzyme Immunoassay, Lidocaine Clinical Toxicology Class 2 862.3555 2007-11-15
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2007-11-15
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-12-14
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2016-12-14
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2024-04-12
LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Immunology Class 2 866.6010 2007-12-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-06-06
PQO Anti-Müllerian Hormone Test System Clinical Chemistry Class 2 862.1092 2023-06-06
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2012-11-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-11-08
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2012-11-08
DHX System, Test, Carcinoembryonic Antigen Immunology Class 2 866.6010 2011-03-25
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2007-12-28
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2007-12-28
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2017-06-07
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-06-07
JKR Radioimmunoassay, Calcitonin Clinical Chemistry Class 2 862.1140 2019-01-08
MLM Enzyme Immunoassay, Tracrolimus Clinical Chemistry Class 2 862.1678 2007-11-15
DIP Enzyme Immunoassay, Diphenylhydantoin Clinical Toxicology Class 2 862.3350 2007-11-19
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2008-01-07
KEW Slides, Microscope Pathology Class 1 864.3010 2005-09-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-01-02
DHX System, Test, Carcinoembryonic Antigen Immunology Class 2 866.6010 2008-01-02
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2008-01-02
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2008-01-02
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2008-01-02
LOQ Device, General Purpose, Hematology Immunology Class 2 866.6010 2008-01-02
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2008-01-02
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2008-01-02
NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer Immunology Class 2 866.6010 2008-01-02
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2008-01-02
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2008-01-02
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2008-01-02
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2008-01-02
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2008-01-02
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2008-01-02
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2008-01-02
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-01-02
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-01-02
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2008-01-02
JFT Fluorometric, Cortisol Clinical Chemistry Class 2 862.1205 2008-01-02
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2008-01-02
LGS Fluorescence Polarization Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2008-01-02
LFM Enzyme Immunoassay, Digitoxin Clinical Toxicology Class 2 862.3300 2008-01-02
LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Immunology Class 2 866.6010 2008-01-02
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2008-01-02
LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) Clinical Toxicology Class 2 862.3350 2008-01-02
LCD Enzyme Immunoassay, Gentamicin Clinical Toxicology Class 2 862.3450 2008-01-02
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2008-01-02
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2008-01-02
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2008-01-02
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2008-01-02
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2008-01-02
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2008-01-02
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2008-01-02
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2008-01-02
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-01-02
LCR Fluorescent Immunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2008-01-02
GWG Endoscope, Neurological Neurology Class 2 882.1480 2008-01-02
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2008-01-02
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2008-01-02
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2008-01-02
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2026-06-19
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2023-09-07
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2023-08-02
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2009-05-28
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2008-01-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-01-21
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2002-05-07
CDX Radioimmunoassay, Total Thyroxine Clinical Chemistry Class 2 862.1700 2007-12-28
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 1982-12-10
JCN Control, Cell Counter, Normal And Abnormal Hematology Class 2 864.8625 2011-06-28
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2008-01-18
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2008-01-18
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2008-01-18
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2008-01-18
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2008-01-18
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2008-01-18
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2008-01-18
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2008-01-18
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2008-01-18
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2008-01-18
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2008-01-18
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2008-01-18
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2016-04-19
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2011-06-28
CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2012-08-01
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2012-08-01
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-04-11
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2008-01-09
JQA Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes Clinical Chemistry Class 1 862.1360 2011-06-29
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2012-02-03
LKP Anti-Sm Antibody, Antigen And Control Immunology Class 2 866.5100 2008-01-07
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2008-01-09
LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects Unknown Class 3 N/A 2014-05-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-01-07
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2011-08-03
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2013-04-10
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Immunology Class 2 866.5775 2013-04-10
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2011-06-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-04-06
KRY Calibrator For Platelet Counting Hematology Class 2 864.8175 2015-05-07
KSA Calibrator For Red-Cell And White-Cell Counting Hematology Class 2 864.8185 2015-05-07
KRX Calibrator For Cell Indices Hematology Class 2 864.8150 2015-05-07
KRZ Calibrator For Hemoglobin And Hematocrit Measurement Hematology Class 2 864.8165 2015-05-07
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-01-07
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 1999-11-17
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2008-10-21
GKP Instrument, Coagulation, Automated Hematology Class 2 864.5400 2008-10-21
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2023-04-10
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2020-01-22
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2017-08-21
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2017-08-21
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2017-08-21
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-06-28
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2008-01-09
LCD Enzyme Immunoassay, Gentamicin Clinical Toxicology Class 2 862.3450 2008-01-09
LED Stains, Chemical Solution Hematology Class 1 864.1850 2025-12-15
BXK Gas, Calibration (Specified Concentration) Anesthesiology Class 1 868.6400 2020-07-02
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-07-18
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2005-05-12
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2007-12-27
LAR Enzyme Immunoassay, Procainamide Clinical Toxicology Class 2 862.3320 2007-11-15
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2010-06-08
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2011-01-21
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2022-02-15
KLB Radioimmunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2008-01-09
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2005-05-12
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2011-06-29
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2007-12-28
JIF Enzymatic Method, Ammonia Clinical Chemistry Class 1 862.1065 2013-02-27
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-01-07
JIF Enzymatic Method, Ammonia Clinical Chemistry Class 1 862.1065 2008-01-07
JHN Turbidimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 2011-07-28
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2019-07-02
OVK Cytokeratin Fragments 21-1 Eia Kit Immunology Class 2 866.6010 2026-03-16
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2011-06-28
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-06-28
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Microbiology Class 2 866.3305 2018-09-04
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2013-01-04
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control Immunology Class 2 866.5600 2013-01-04
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2014-11-24
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2014-11-24
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2014-11-24
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2014-11-24
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2014-11-24
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2014-11-24
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-11-24
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2014-11-24
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2014-11-24
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2014-11-24
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2014-11-24
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2014-11-24
NDY Test, Cystatin C Clinical Chemistry Class 2 862.1225 2018-06-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIEMENS HEALTHCARE DIAGNOSTICS INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Other Registrations for Same Entity

Registration Number Establishment Name Location
3012817228 Epocal Inc Ottawa Ontario, CA
3011194542 Siemens Healthcare GmbH Berlin, DE
3009448641 Siemens Healthcare Diagnostics, Inc. Mishawaka, IN, US
3004959793 EPOCAL, INC. Ottawa Ontario, CA
9610633 SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD SUDBURY Suffolk, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K920820 Helena Laboratories MODIFICATION COLUMNMATE 1992-08-17
K991850 Biosafe Laboratories, Inc. SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC 1999-11-26
K171771 Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay 2017-12-04
K882259 Diagnostic Chemicals, Ltd. (Usa) DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 1988-07-21
K060322 Cliniqa Corporation CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED 2006-03-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2014 Siemens Healthcare Diagnostics 2
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0072-2017 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Centaur XPT Immunoassay System
Z-0081-2017 Siemens Healthcare Diagnostics, Inc. 2
SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Z-0082-2017 Siemens Healthcare Diagnostics, Inc. 2
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Z-0101-2021 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021 Siemens Healthcare Diagnostics, Inc. 2
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637
Z-0104-2023 Siemens Healthcare Diagnostics, Inc. 2
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Z-0105-2023 Siemens Healthcare Diagnostics, Inc. 2
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Z-0148-2020 Siemens Healthcare Diagnostics, Inc. 2
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2432235. Last updated year: 2026. Please use registration number 2432235 when referencing this establishment in official correspondence.
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