Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010939897

FEI Number

3010939897

Entity Name

Microgenics Corporation

City/State/Country

Fremont, CA, US

Establishment Address

46500 Kato Road, Fremont, CA 94538, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Thermo Fisher Scientific (Owner Number: 2517925)

Owner / Operator Contact Address

168 Third Avenue, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MULTIGENT Opiates Assay DRI Opiates Assay Alinity c Opiates Reagent Kit MULTIGENT OPIATES LOW CONTROL MULTIGENT Tox Controls MULTIGENT Ecstasy Calibrators for Architect MULTIGENT Ethanol Assay DRI Ethanol Assay Alinity c Ethanol Reagent Kit Alinity c Cocaine DRI Cocaine Metabolite Assay CEDIA N-Acetylprocainamide Assay (NAPA) Abbott Phenobarbital Assay Alinity c Phenobarbital Reagent Kit CEDIA Methadone Metabolite (EDDP) Assay Multigent Amikacin Alinity c Amikacin Reagent Kit QMS Amikacin MAS DOA Total Liquid Assayed Drugs of Abuse Control MGC Clinical DAU Control Set MGC Select DAU Control Set Siemens QC Toxicology Control CEDIA Specialty Control Set MAS PAR TDM Liquid Assayed Therapeutic Drug Control MAS Tox Control Alinity c Tox Controls MGC Primary DAU Control Set CEDIA MultiDrug Optional Controls Alinity c DOA MC III Controls Alinity c DOA MC II Controls Alinity c DOA MC I Controls Architect Tox Controls Architect Rubella Control Kit Architect MPO Control Kit Alinity i T-Uptake Controls Alinity c Microalbumin Reagent Kit ARCHITECT B.R.A.H.M.S PCT Controls Multigent Digoxin DRI Digoxin Alinity c Digoxin Reagent Kit Siemens Atellica CH Tox Cal Siemens ToxAmmonia Calibrator Alinity c ICT Serum Calibrator Kit Alinity c Bilirubin Calibrator Kit Alinity c Multiconstituent Calibrator Kit Alinity c Carbon Dioxide Calibrator Kit Atellica CH Chemistry Calibrator Urine/CSF Protein Calibrator Aliniity c Iron Calibrator Kit Carbon Dioxide Calibrator (Architect) Multiconstituent Calibrator (Architect) ICT Serum Calibrator Kit Bilirubin Calibrator (Architect) Atellica CH A-LYTE IMT Dilution Check Alinity c Urine/CSF Protein Calibrator Kit CEDIA Phencyclidine Assay CEDIA Mycophenolic Acid Assay MULTIGENT Opiates Low Calibrators QMS® Vancomycin Reagents Multigent Vancomycin Alinity c Vancomycin Reagent Kit Alinity c Ethanol Control Kit MAS Tox Control Ammonia DRI Alcohol Controls QMS Lamotrigine Assay 125I T3 UPTAKE RADIOASSAY KIT ARCHITECT T-Uptake DRI T-Uptake (EIA Assay) Alinity i T-Uptake Reagent Kit DRI T-Uptake Calibrator Kit CEDIA T-Uptake Assay Oral Eze - Oral Fluid Collection System QMS Topiramate MULTIGENT Benzodiazepines Assay DRI Ecstasy Assay MULTIGENT Ecstasy Assay Alinity c Ecstacy Reagent Kit MULTIGENT Cannabinoids Controls TDM Multiconstituent Calibrator Multiconstituent Calibrator CEDIA Multi-level THC Assay MULTIGENT Cocaine Assay DRI Cocaine Metabolite Alinity c Cocaine Reagent Kit Thermo Scientific HEMA-TROL¿ Whole Blood HGB CEDIA Tobramycin II Assay DRI Ecstasy Plus Assay DRI TM Tricyclics Serum Tox Assay Siemens Dimension Vista Digitoxin Calibrator CEDIA Amphetamine OFT Assay CRP Liquid Assayed Control MAS Advanced Immunology Controls DRI Cotinine Assay DRI Cotinine Controls DRI Cotinine Calibrator Kit Dimension Vista® Chemistry 1 Calibrator CEDIA Benzodiazepine Assay DRI Phencyclidine Assay MULTIGENT Phencyclidine (PCP) Alinity c Phencyclidine Reagent Kit MULTIGENT Tox Calibrators Sentry Urine Dipstick Control MAS UA Control MAS Urinalysis Controls MAS UrichemTrak Urine Control DRI Cotinine High Control DRI Cotinine Low Control Abbott Iron/Mag Cal Carbon Dioxide Calibrator Bilirubin Calibrator Abbott Theophylline Assay Alinity C Theophylline Reagent Kit Siemens Dimension Vista Chemistry 2 Calibrator Multigent Valproic Acid Alinity c Valproic Acid Reagent Kit QMS Everolimus Calibrator DRI Acetaminophen Serum Tox Assay DRI Barbiturate Serum Tox Assay Siemens ADVIA® Chemistry Serum Barbiturate CEDIA Methamphetamine OFT Assay DRI Methaqualone Assay CEDIA Amphetamine/Ecstasy Assay CEDIA Valproic Acid II Assay Dimension Vista® Chemistry 1 Calibrator Alinity c Carbon Dioxide Calibrator Bilirubin Calibrator Multiconstituent Calibrator Alinity c Urine/CSF Protein Calibrator Kit Alinity c Iron Calibrator Kit Alinity i Anti-TPO Controls Carbon Dioxide Calibrator Alinity i T-Uptake Controls AcroMetrix Negative Control Alinity i Anti-TPO Controls AcroMetrix HBV High Control AcroMetrix HIV-1 Low Control Acrometrix EV Low Control Acrometrix BB NAT HBV Positive Control AcroMetrix HCV High Control Alinity i Anti-Tg Controls AcroMetrix HIV-1 High Control AcroMetrix HIV-1 Mid Control Alinity i BRAHMS PCT Controls AcroMetrix HBV Low Control AcroMetrix BKV Low Control AcroMetrix HCV Mid Control MAS PTH Control AcroMetrix HCV Low Control AcroMetrix HBV Mid Control AcroMetrix BKV High Control Alinity c Cannabinoids Control 2 Kit MAS Diabetes Control Acrometrix EBV High Plasma Control MAS Bilirubin Control Acrometrix EV Negative Control DRI THC Urine Controls Acrometrix EBV Low Plasma Control MAS CardioImmune UL Alinity c Cannabinoids Control 1 Kit MAS SARS-CoV-2 IgG Positive Control MAS SARS-CoV-2 Negative Control MAS Diabetes Max Control DRI Amphetamine Assay Multigent Amphetamine/Methamphetamine Assay Alinity c Amphetamine/Methamphetamine Reagent Kit CEDIA Procainamide Assay Carbamazepine Assay for Architect Alinity c Carbamazepine Reagent Kit Alinity c Tricyclic Antidepressant Reagent Kit DRI Tricyclic Serum Tox Assay CEDIA TDM Cardiac Calibrators Glypican-3 RTU 12ml p53 Ab-5 1mL Dewax and HIER Buffer M(15x concentrate) 10x100mL Lambda Light Chain Ab-2 0.1mL Mesothelioma RTU 7ml TdT / Terminal Deoxyribonucleotidyl Transferase RTU 12ml CD4 0.5mL Amyloid Precursor Protein (APP) 1mL Epithelial Specific Antigen (Ep-CAM) Ab-1 0.5mL CD23 [SP23] 0.1mL Factor VIII Related Antigen / von Willebrand Factor Ab-2 RTU 7ml Synuclein alpha RTU 7ml Follicle Stimulating Hormone (FSH) 0.5mL DAB Quanto 4ml Chromogen 125mlSubstrate Mucin 5AC (MUC-5AC) / Gastric Mucin 1mL Actin, Smooth Muscle 1mL Keratin 5 Ab-1 0.1mL Synuclein alpha 1mL Kappa Light Chain Ab-2 0.1mL Androgen Receptor 0.5mL MLH1 [4C9C7] 1 mL Mucin 2 (MUC-2) RTU 7ml ALK (Anaplastic Lymphoma Kinase) / p80 RTU 7ml Glycophorin A 1mL Mesothelioma 0.5mL Hepatocyte RTU 12ml Renal Cell Carcinoma Marker(gp200) RTU 12ml COX2 RTU 12ml CD3 (Early T Cell Marker) RTU 7ml CD34 [QBEnd/10] 0.1mL E-Cadherin 0.1mL CD15 1mL Tartrate Resistant Acid Phosphatase (TRAP)Ab-1 0.5mL Cyclin D1 [EPR2241IHC] RTU 7ml E-Cadherin RTU 7ml Immunoglobulin M (IgM), Polyclonal FITC Labeled GLUT-1 [SPM498] RTU 7ml UltraVision Large Vol Anti-Polyvalent, AP (RTU) 125mL Glycophorin A 0.1mL UltraVision Protein Block 1L p53 Ab-8 0.1mL Keratin 17 0.1mL CD105 / Endoglin / TGF beta 1/3 Receptor 0.5mL Estrogen Receptor [1D5] 0.5 mL ASR Desmin (Muscle Cell Marker) Ab-1 1mL D2-40 [D2-40] RTU 12ml CD4 0.1mL Chromogranin A [SP12] 1mL Prostate Specific Membrane Antigen (PSMA) [SP29] 1mL CD30 (Reed-Sternberg Cell Marker) Ab-1 0.1mL Epithelial Membrane Antigen / EMA 0.1mL Topoisomerase II alpha 0.5mL Keratin 7 0.1mL Actin, Smooth Muscle RTU 7ml Epstein-Barr Virus / LMP 1mL ASR Estrogen Receptor RTU[1D5+6F11] 7 Ml ASR Placental Lactogen (hPL) 1mL Synuclein alpha 0.5mL UV Hydrogen Peroxide Block125ml Factor VIII Related Antigen / von Willebrand Factor Ab-1 RTU 7ml CD2 (LFA-2) 1mL COX2 1mL CD20 [EP459Y] 0.1mL p120 Catenin [EP66] 1mL CD8 [SP16] RTU 7ml CD5 [SP19] 0.1mL Synuclein alpha 0.1mL MART-1 / Melan-A RTU 7ml IgM (mu-Heavy Chain) RTU 7ml CD10/CALLA (Neutral Endopeptidase) RTU 7ml CD2 (LFA-2) RTU 7ml Tartrate Resistant Acid Phosphatase (TRAP)Ab-1 0.1mL Prostate Specific Acid Phosphatase (PSAP) RTU 7ml COX2 0.5mL BCL-6 [LN22] RTU 7ml Cyclin D1 / Bcl-1 [SP4] RTU 12 mL Calcitonin RTU 12ml TAG-72 / CA 72-4 [B72.3] 1ML Epithelial Specific Antigen (Ep-CAM) Ab-1 0.1mL CD3 (Early T Cell Marker) 0.5mL S100 1mL CD138 RTU 12ml CD34 [QBEnd/10] RTU 7ml Desmin (Muscle Cell Marker) 0.5mL Keratin 14 1mL Keratin 10 1mL CD21 RTU 7ml Myeloperoxidase (MPO) 0.5mL p53 Ab-5 0.1mL IgD (delta-Heavy Chain) RTU 7ml Melanoma (gp100) 0.5mL PT Module Deparaffin. and HIER Solution (100X) pH9 125mL Keratin 8 0.1mL Keratin 14 RTU 7ml Mucin 5AC (MUC-5AC) / Gastric Mucin RTU 7ml CDw75 0.1mL Granzyme B 0.1mL MSH6 [EPR3945] 0.1 mL CD8 Ab-1 1mL Estrogen Receptor [1D5] RTU 7ml ASR TAG-72 / CA 72-4 [B72.3] RTU 7ml UltraVision LP HRP Polymer & DAB Plus Chromogen 60mL c-erbB-2 / HER-2 / neu [SP3] 0.5mL ASR Beta-catenin 1mL IgD (delta-Heavy Chain) 0.1mL Vimentin 1mL Caldesmon, HMW 0.5mL Synaptophysin (Neuroendocrine Marker) RTU 7ml MART-1 / Melan-A 0.5mL E-Cadherin 1mL UltraVision LP Large Vol AP Polymer (RTU) 125mL MLH1 [4C9C7] RTU 12 mL GCDFP-15 (Gross Cystic Disease Fluid Protein-15) RTU 12ml Caldesmon, HMW 1mL Tyrosinase RTU 12ml CDw75 RTU 7ml Anti-Cytomegalovirus 1mL RTU[CCH2+DD] ASR Estrogen Receptor [1D5+6F11]1mL ASR CD138 RTU 7ml BCL-2alpha 0.1mL Follicle Stimulating Hormone (FSH) 1mL Alpha Fetoprotein (AFP) RTURTU 12ml Human Papilloma Virus (HPV)[K1H8] RTU 12ml ASR CD5 [SP19] 0.5mL Myeloperoxidase (MPO) RTU 7ml CD79a / mb-1 (B-Cell Marker) [SP18] 0.5mL CD31 / PECAM-1 (Endothelial Cell Marker) 1mL Keratin 7 RTU 12ml IgE (epsilon-Heavy Chain) RTU 7ml PT Module Deparaffin. and HIER Solution (100X) pH8 250mL Keratin 5 Ab-1 0.5mL BCL-2alpha RTU 7ml UltraVision Large Vol Anti-Polyvalent, HRP (RTU) 125mL Calretinin RTU 7ml Glypican-3 RTU 7ml ALK (Anaplastic Lymphoma Kinase) / p80 Ab-1 RTU 7ml Keratin, Pan 0.5mL BOB1 [SP92] 0.1 mL Catenin, beta RTU 7ml Alpha Fetoprotein (AFP) 0.1mL CD3epsilon (Early T-Cell Marker) RTU 7ml Keratin 8/18 Ab-1 1mL PT Module Deparaffin. and HIER Solution (100X) pH8 125mL CD5 [EP2952] 1mL Epithelial Membrane Antigen / EMA RTU RTU 7ml Lambda Light Chain Ab-1 1mL p120 Catenin [EP66] 0.1mL Myeloperoxidase (MPO) 0.1mL Large Vol Phosphate Buffered Saline (25X) 125mL IgG (gamma-Heavy Chain) 1mL Calponin 1mL Myelin Basic Protein Ab-1 1mL Placental Lactogen (hPL) 0.5mL Helicobacter pylori RTU 7ml ASR Follicle Stimulating Hormone (FSH) RTU 7ml CA 125 (Ovarian Cancer Antigen) 0.1mL Placental Alk. Phosphatase(PLAP) RTU 12ml p504S/ AMACR [13H4] 0.1mL ASR Dewax and HIER Buffer H(15x concentrate) 10x100mL Keratin 5 Ab-1 1mL Napsin-A [EPR6252] 0.1mL Factor VIII Related Antigen / von Willebrand Factor Ab-2 0.5mL IgA (alpha-Heavy Chain) 1mL BOB1 [SP92] RTU 7 mL MSH6 [EPR3945] 1 mL CD30 (Reed-Sternberg Cell Marker) Ab-4 RTU 7ml p53 Ab-5 RTU 12ml Keratin 7 0.5mL Cyclin D1 [EPR2241IHC] 1mL Epidermal Growth Factor Receptor (EGFR) [EP38Y] 0.1mL TdT / Terminal Deoxyribonucleotidyl Transferase RTU 7ml IgM (mu-Heavy Chain) 0.1mL UltraVision ONE, AP Polymer & Fast Red Chromogen 15mL CD31 / PECAM-1 (Endothelial Cell Marker) RTU 7ml Pax-5 [SP34] 0.1mL Keratin 19 RTU 12ml CA 125 (Ovarian Cancer Antigen) 1mL DOG-1 0.1mL Anti-Cytomegalovirus 0.1mL[CCH2+DD] ASR CD10/CALLA (Neutral Endopeptidase) 1mL p53 Ab-8 1mL Napsin-A [EPR6252] 1mL Anti-Glial Fibrillary AcidicProtein (GFAP) [EP13] RTU 7ml Human Papilloma Virus (HPV)[K1H8] 0.1mL ASR Keratin 18 Ab-1 0.1mL Luteinizing Hormone, Human (LH) 0.5mL Vimentin Ab-2 RTU 7ml UltraVision Anti-Polyvalent, HRP/AEC (RTU) 15mL CDX2 [EPR2764Y] RTU 7ml c-erbB-2 / HER-2 / neu Ab-17 1mL ASR Epithelial Membrane Antigen / EMA 1mL Myeloperoxidase (MPO) RTU 12ml CD99 / MIC2 (Ewings Sarcoma Marker) 1mL CDX2 [EPR2764Y] 1mL DOG-1 RTU 7ml Myelin Basic Protein Ab-1 RTU 7ml D2-40 [D2-40] 0.1mL CD30 (Reed-Sternberg Cell Marker) Ab-1 1mL Adrenocorticotrophic Hormone (ACTH) 0.1mL Prostate Specific Acid Phosphatase (PSAP) 0.1mL Estrogen Receptor [1D5+6F11]0.5mL ASR GLUT-1 [SPM498] 0.1mL NY-BR-1 0.1mL Glycophorin A 0.5mL CD45RO (T-Cell Marker) RTU 7ml CD23 [SP23] RTU 7ml Fascin 1mL Placental Alk. Phosphatase (PLAP) 0.5mL CD68 / Macrophage Marker Ab-3 0.1mL Factor VIII Related Antigen / von Willebrand Factor Ab-2 1mL EDTA Buffer for HIER (10X) 125mL Androgen Receptor 0.1mL S100 Protein RTU 12ml IgD (delta-Heavy Chain) 0.5mL Gastrin 0.1mL Actin, Smooth Muscle [1A4] RTURTU 12ml UltraVision LP AP Polymer & Fast Red Chromogen 15mL Factor XIII A 1mL CD7 [EPR4242] 0.1 mL Anti-Cytomegalovirus 1mL[CCH2+DD] ASR Keratin 10 0.1mL Keratin 8/18 Ab-1 0.1mL CD15 0.1mL PMS2 [EPR3947] RTU 12ml ALK (Anaplastic Lymphoma Kinase) / p80 0.1mL CD31 / PECAM-1 (Endothelial Cell Marker) 0.5mL Alpha Fetoprotein (AFP) 1mL Macrophage / L1 Protein / Calprotectin 0.1mL UltraVision Protein Blk 125ml Anti-Factor XIII A [EP3372] 1mL CD5 [EP2952] RTU 12ml Pax-5 0.5mL Cyclin D1 / Bcl-1 [SP4] 0.5mL Keratin 8 / 18 RTU 7ml ALK (Anaplastic Lymphoma Kinase) / p80 Ab-1 0.1mL Anti-Cytomegalovirus 12mL RTU[CCH2+DD] ASR CD30 (Reed-Sternberg Cell Marker) Ab-4 0.5mL PSA [EP1588Y] 1mL ASR Synaptophysin (Neuroendocrine Marker) 0.5mL Cyclin D1 [EPR2241IHC] RTU12 mL c-erbB2 /HER-2 / neu [EP1045Y]RTU 7ml ASR CD68 / Macrophage Marker Ab-3 0.5mL Calretinin 0.5mL c-erbB-2 / HER-2 / neu Ab-17 RTU 7ml ASR S100 RTU 12ml UltraVision Quanto Detection System AP 1L Actin, Smooth Muscle [1A4]0.5mL HIER Buffer H, 9 BT/CSTris-EDTA Buffer,15ml/BT Myelin Basic Protein 0.1mL Mucin 1 (MUC-1) RTU 7ml Prostate Specific AcidPhosphatase (PSAP) RTU 12ml DOG-1 RTU 12ml Large Vol Phosphate Buffered Saline and Tween 20 (20X) 125mL Factor VIII Related Antigen / von Willebrand Factor Ab-1 0.1mL Kappa Light Chain Ab-1 0.5mL CD3epsilon RTU 12ml Fascin 0.1mL UltraVision Quanto DetectionSystem HRP 60mL Vimentin Ab-2 RTU 12ml Desmin (Muscle Cell Marker) Ab-1 RTU 12 mL Myeloperoxidase (MPO) 1mL COX2 0.1mL CA19-9 / Sialyl Lewis a (GI Tumor Marker) 0.5mL UltraVision Large Vol Anti-Polyvalent, AP (RTU) 60mL CD23 RTU 12ml Vascular Endothelial GrowthFactor (VEGF) RTU 12ml ASR CD5 0.5mL Chromogranin A [SP12] RTU 7ml Keratin, Pan RTU 7ml Keratin 5 Ab-1 RTU 7ml Alpha Fetoprotein (AFP) 0.5mL Dystrophin RTU 7ml c-erbB2 / HER-2 / neu[EP1045Y] RTU 12ml ASR Luteinizing Hormone, Human (LH) RTU 7ml Calretinin [SP13] 1mL MART-1 / Melan-A 1mL PMS2 [EPR3947] RTU 7ml Tris Buffer Saline and Tween 20 Large Vol (20X) 999mL Keratin, HMW Ab-3 RTU 7ml Calcitonin 0.5mL Calretinin 0.1mL CD10/CALLA (Neutral Endopeptidase) RTU 12ml Biotinylated Goat Anti-Polyvalent (RTU) 125mL Keratin 8/18 Ab-1 RTU 7ml Smooth Muscle Myosin HeavyChain 0.1 mL [EPR5336(B)] CD5 [EP2952] RTU 7ml GLUT-1 [SPM498] 0.5mL CDw75 1mL UltraVision ONE Large Vol, AP Polymer (RTU) 60mL Tyrosinase RTU 7ml CD57 (Natural Killer Cell Marker) 0.5mL S100 0.5mL Lysozyme / Muramidase RTU 7ml p21 WAF1 0.1mL Calcitonin RTU 7ml Keratin 10 0.5mL Actin, Muscle Specific 1mL Estrogen Receptor [1D5] 0.1 mL ASR Keratin 18 RTU 12ml Calponin 0.5mL MLH1 [4C9C7] 0.1 mL Human Papilloma Virus (HPV)[K1H8] 1mL ASR E-Cadherin RTU 12ml Amyloid Precursor Protein (APP) 0.5mL CDX2 [EPR2764Y] 0.1mL CD20 Ab-1 0.5mL Factor VIII Related Antigen / von Willebrand Factor Ab-1 0.5mL CD45RO (T-Cell Marker) 0.5mL Renal Cell Carcinoma Marker (gp200) 0.1mL CD34 [QBEnd/10] RTU 12ml Villin 0.1mL Keratin 8 / 18 0.5mL Keratin 18 0.1mL Keratin, HMW Ab-3 RTU 12ml CD5 [SP19] RTU 12ml CD5 RTU 12ml Epithelial Specific Antigen (Ep-CAM) Ab-1 1mL Hepatocyte 1mL AP Polymer Quanto Myelin Basic Protein RTU 7ml MAP 2a,b,c (Microtubule-Associated Protein) 0.5mL CD3 (Early T Cell Marker) RTU 12 mL Keratin 7 RTU 7ml p57 Kip2 Ab-6 1mL CD2 (LFA-2) 0.1mL MART-1 / Melan-A 0.1mL Protease XXV for Enzyme-Induced Epitope Retrieval 2mL Vascular Endothelial Growth Factor (VEGF) 0.1mL ASR Melanoma (gp100) RTU 7ml ERG [9FY] 1mL c-erbB2 /HER-2 / neu [EP1045Y]] 0.1mL ASR CD3epsilon (Early T-Cell Marker) 0.1mL Fast-Red Substrate System 60mL MultiVision CD3 epsilon [F7.2.38] + Ki-67 [SP6] Pax-5 [SP34] RTU 7ml UltraVision Quanto DetectionSystem HRP DAB 125mL Troponin T, Cardiac Isoform0.1ML Calponin 0.1mL CD1a 0.1mL GLUT-1 RTU 7ml S100 0.1mL Keratin 20 1mL Mucin 1 (MUC-1) 1mL Alpha Fetoprotein (AFP) RTU 7ml CA 125 (Ovarian Cancer Antigen) RTU 12ml Keratin 19 1mL EDTA Buffer for HIER (10X) 500mL Pepsin Solution for Enzyme-Induced Epitope Retrieval 5mL Tyrosinase 0.1mL Protease XXV for Enzyme-Induced Epitope Retrieval 5mL IgM (mu-Heavy Chain) 0.5mL c-erbB-2 / HER-2 / neu [SP3] 0.1mL ASR UltraVision ONE, HRP Polymer & DAB Plus Chromogen 15mL CD44 Std. / HCAM 1mL Adrenocorticotrophic Hormone (ACTH) 1mL Keratin 5 / 6 0.5mL IgG (gamma-Heavy Chain) 0.5mL Vascular Endothelial Growth Factor (VEGF) RTU 7ml ASR CD2 (LFA-2) 0.5mL Dewax and HIER Buffer (H,M,L)Variety Pack (15x concentrate) DOG-1 [SP31] RTU 7ml MAP 2a,b,c (Microtubule-Associated Protein) RTU 7ml Granzyme B 1mL CD138 1mL Chromogranin A [SP12] RTU 12ml Neurofilament (200kDa & 68kDa) 1mL CD79a / mb-1 (B-Cell Marker) [SP18] RTU 7ml AEC Substrate System (RTU) 60mL UltraVision LP HRP Polymer & DAB Plus Chromogen 15mL p53 RTU 7ml p21 WAF1 RTU 7ml Vimentin RTU 7ml Synaptophysin (Neuroendocrine Marker) 1mL PSA [EP1588Y] RTU 12mL ASR Kappa Light Chain Ab-1 RTU 7ml Thyroid Transcription Factor-1 (TTF-1) 1mL Keratin, HMW Ab-3 1mL Epithelial Membrane Antigen / EMA 0.5mL AEC Substrate System (RTU) 125mL DAB Quanto 2ml Chromogen 60mlSubstrate GCDFP-15 (Gross Cystic Disease Fluid Protein-15) 0.5mL UltraVision Quanto DetectionSystem HRP 125mL CD57 (Natural Killer Cell Marker) RTU 7ml Factor XIII A RTU 7ml HIER Buffer L, 9 BT/CSCitrate Buffer,15ml/BT Human Papilloma Virus (HPV)[K1H8] 0.5mL ASR ERG [9FY] RTU 7ml Dystrophin 1mL Renal Cell Carcinoma Marker (gp200) 1mL Actin, Muscle Specific 0.5mL Fascin RTU 7ml ZAP-70 [2F3.2] 0.5mL BCL-2alpha RTU 12ml IgG (gamma-Heavy Chain) RTU 7ml Melanoma (gp100) RTU 12ml CD20 1mL Ki-67 [SP6] RTU 7ml Actin, Smooth Muscle [1A4]0.1ml Placental Alk. Phosphatase(PLAP) Ab-4 RTU 7ml CD20 Ab-1 RTU 12ml CD20 [EP459Y] 1mL BCL-2alpha 1mL DOG-1 [SP31] RTU 12ml Dystrophin 0.1mL Keratin, HMW Ab-3 0.5mL CD79a / mb-1 (B-Cell Marker) [SP18] 0.1mL Troponin T, Cardiac Isoform0.5mL Perforin 0.1mL Perforin 0.5mL Desmin (Muscle Cell Marker) 1mL Topoisomerase II alpha RTU 12ml Anti-Factor XIII A [EP3372] RTU 7ml CD23 [SP23] 0.5mL Keratin 8 / 18 1mL UltraVision Quanto DetectionSystem AP 60mL Actin, Smooth Muscle [1A4] 1mL TAG-72 / CA 72-4 [B72.3]0.1mL Placental Alk. Phosphatase (PLAP) Ab-4 1mL Macrophage / L1 Protein / Calprotectin RTU 7ml Prostate Specific Acid Phosphatase (PSAP) 0.5mL Large Vol Tris Buffer Saline and Tween 20 (20X) 125mL Topoisomerase II alpha 1mL Keratin 5 RTU 7ml Helicobacter pylori 0.5mL ASR MART-1 / Melan-A RTU 12ml p53 Ab-8 0.5mL Serotonin 0.5mL CD117 / c-Kit / SCF-ReceptorRTU 12ml Epidermal Growth Factor Receptor (EGFR) [EP38Y] 1mL IgE (epsilon-Heavy Chain) 1mL Mucin 1 (MUC-1) 0.1mL Neurofilament (200kDa & 68kDa) RTU 7ml CD10/CALLA (Neutral Endopeptidase) 0.1mL Catenin, beta 0.5mL Citrate Buffer for HIER 500mL Tartrate Resistant Acid Phosphatase (TRAP)Ab-1 1mL Primary Antibody EnhancerPrimary Antibody Enhancer CA 125 (Ovarian Cancer Antigen) 0.5mL Protein Gene Product 9.5 0.5mL Mucin 5AC (MUC-5AC) / Gastric Mucin 0.1mL Epithelial Membrane Antigen / EMA 1mL Thyroid Transcription Factor-1 (TTF-1) RTU 7ml PSA [EP1588Y] 7mL ASR Villin 1mL Biotinylated Goat Anti-Polyvalent (RTU) 60mL Lambda Light Chain Ab-1 0.1mL Synaptophysin (NeuroendocrineMarker) RTU 12ml Actin, Smooth Muscle 0.1mL CD8 [SP16] RTU 12ml Anti-Factor XIII A [EP3372] RTU 12ml TAG-72 / CA 72-4 [B72.3] RTU 12ml Epithelial Membrane Antigen / EMA 0.1mL Calponin RTU 12ml Placental Alk. Phosphatase (PLAP) 0.1mL CD23 0.1mL Phosphate Buffered Saline andTween 20 Large Vol (20X) 999mL Keratin 19 0.5mL Epithelial Membrane Antigen / EMA RTU 7ml CD23 [SP23] 1mL Protein Gene Product 9.5 1mL Hepatocyte RTU 7ml HRP Polymer Quanto Citrate BuB2:B1045ffer for HIER 125mL Gastrin 1mL CD105 / Endoglin / TGF beta 1/3 Receptor RTU 7ml CD7 [EPR4242] RTU 12 mL Keratin 17 0.5mL Follicle Stimulating Hormone (FSH) 0.1mL Luteinizing Hormone, Human (LH) 0.1mL Anti-Cytomegalovirus 7mL RTU[CCH2+DD] ASR Epstein-Barr Virus / LMP 0.5mL ASR CD4 RTU 12ml CD21 0.1mL Progesterone Receptor [YR85]0.1mL ASR Progesterone Receptor[hPRa 2+hPR 3] RTU 12ml ASR Catenin, beta 1mL p120 Catenin [EP66] RTU 1mL Calretinin [SP13] 0.5mL Gastrin 0.5mL Troponin T, Cardiac IsoformRTU 7 ml Placental Lactogen (hPL) 0.1mL CD56 / NCAM-1 1mL Tris-HCl Buffer for HIER (10X) 500mL TdT / Terminal Deoxyribonucleotidyl Transferase 1mL UltraVision ONE Large Vol, HRP Polymer (RTU) 60mL Keratin 8 0.5mL Kappa Light Chain Ab-1 1mL CA19-9 Sialyl Lewis a GI Tumor Marker RTU 7ml Granzyme B RTU 12ml CDw75 0.5mL Keratin 19 RTU 7ml Keratin 8 RTU 12 ML BCL-2alpha 0.5mL Large Vol Tris Buffered Saline (25X) 125mL TdT / Terminal Deoxyribonucleotidyl Transferase 0.5mL CD56 / NCAM-1 0.1mL GCDFP-15 (Gross Cystic Disease Fluid Protein-15) 0.1mL Keratin 5 0.1mL Actin, Muscle Specific RTURTU 12ml CD31 / PECAM-1 (Endothelial Cell Marker) 0.1mL CD68 / Macrophage Marker Ab-3 RTU 12 mL CD138 0.5mL Melanoma (gp100) 0.1mL CD23 0.5mL Prostate Specific Membrane Antigen (PSMA) [SP29] RTU 7ml Androgen Receptor 1mL Kappa Light Chain Ab-2 1mL CD117 / c-Kit / SCF-Receptor RTU 7ml CD105 / Endoglin / TGF beta 1/3 Receptor 1mL CD30 (Reed-Sternberg Cell Marker) Ab-4 1mL CD45 / T200 / LCA 0.1mL Gastrin RTU 7ml CD5 0.1mL CD1a RTU 7ml Luteinizing Hormone, Human (LH) 1mL Keratin, Low Molecular Weight 1mL Cyclin D1 [EPR2241IHC] 0.1mL CD45RO (T-Cell Marker) RTU 12ml Anti-glial fibrillary acidicprotein (GFAP) [EP13] 0.1mL Kappa Light Chain Ab-2 RTU 7ml Keratin 5 / 6 1mL Keratin 5 / 6 RTU 7ml Catenin, beta 0.1mL MAP 2a,b,c (Microtubule-Associated Protein) 1mL Dystrophin 0.5mL Lambda Light Chain Ab-1 0.5mL Serotonin RTU 7ml CA19-9 / Sialyl Lewis a (GI Tumor Marker) 0.1mL Actin, Smooth Muscle [1A4] RTURTU 7ml Macrophage / L1 Protein / Calprotectin 1mL CD34 [QBEnd/10] 1mL COX2 RTU 7ml Keratin, Pan RTU 12ml Keratin, Low Molecular WeightRTU 12ml Keratin 18 Ab-1 0.5mL CD5 [SP19] 1mL Kit UV PV HRP 1L Cyclin D1 / Bcl-1 [SP4] 0.1mL Vimentin Ab-2 0.5mL Liquid Fast-Red Substrate System 125mL Mesothelin RTU 7ml Keratin 10 RTU 7ml CD8 Ab-10.1mL Calponin-1 1mL CD79a / mb-1 (B-Cell Marker) [SP18] 1mL Hepatocyte 0.5mL Liquid Fast-Red Substrate System 60mL UltraVision LP Large Vol HRP Polymer (RTU) 125mL Villin RTU 7ml OCT3/4 (POU5F1) [653108] RTU12 mL ALK (Anaplastic Lymphoma Kinase) / p80 0.5mL Keratin 7 1mL ALK (Anaplastic Lymphoma Kinase) / p80 Ab-1 1mL Mucin 5AC (MUC-5AC) / GastricMucin RTU 12ml CD68 / Macrophage Marker Ab-4 RTU 7ml CD8 [SP16] 0.5mL Napsin-A [EPR6252] RTU 7 mL p120 Catenin [EP66] RTU 12ml Placental Alk. Phosphatase (PLAP) Ab-4 0.1mL UltraVision ONE, HRP Polymer & AEC Chromogen 15mL Keratin 5 / 6 0.1mL Keratin 5 1mL Glypican-3 0.1ML c-erbB-2 / HER-2 / neu [SP3] 1 ml ASR CD8 [SP16] 0.1mL ALK (Anaplastic Lymphoma Kinase) / p80 Ab-1 0.5mL Adrenocorticotrophic Hormone (ACTH) RTU 7ml Keratin 18 1mL Serotonin 0.1mL Chromogranin A 0.1mL CDX2 [EPR2764Y] RTU 12ml Prostate Specific Acid Phosphatase (PSAP) 1mL CD138 0.1mL Caldesmon, HMW RTU 12ml Vimentin 0.1mL Estrogen Receptor [1D5+6F11]0.1mL ASR ERG [9FY] RTU 12ml Calponin RTU 7ml Mesothelioma 1mL CD79a / mb-1 (B Cell Marker) 0.5mL Factor VIII Related Antigen / von Willebrand Factor Ab-2 0.1mL CD10/CALLA (Neutral Endopeptidase) 0.5mL CD56 / NCAM-1 0.5mL Keratin, Low Molecular Weight RTU 7ml CD20 RTU 7ml Desmin (Muscle Cell Marker) Ab-1 0.5mL MAP 2a,b,c (Microtubule-Associated Protein) 0.1mL Pax-5 [SP34] 1mL BOB1 [SP92] RTU 12 mL Mesothelin 0.5mL CD4 RTU 7ml Mesothelioma 0.1mL CD20 Ab-1 0.1mL p53 Ab-5 0.5mL D2-40 [D2-40] RTU 7ml UltraVision LP HRP Polymer & AEC Chromogen 15mL Calponin-1 RTU 12ml Mesothelin 0.1mL CD5 [SP19] RTU 7ml Vimentin 0.5mL Keratin 8 RTU 7ml Epithelial Membrane Antigen / EMA 0.5mL DAB Quanto 1L Topoisomerase II alpha 0.1mL Topoisomerase II alpha RTU 7ml CD3epsilon (Early T-Cell Marker) 0.5mL UltraVision DAB Away 250mL GLUT-1 [SPM498] 1mL CD45RO (T-Cell Marker) 1mL Protein Gene Product 9.5 0.1mL Human Papilloma Virus (HPV)[K1H8] RTU 7ml ASR CD79a / mb-1 (B Cell Marker) 0.1mL CD117 / c-Kit / SCF-Receptor 1mL CD8 Ab-1 RTU 7ml Anti-Factor XIII A [EP3372] RTU 1mL PT Module Deparaffin. and HIER Solution (100X) pH6 250mL Thyroid Transcription Factor-1(TTF-1) RTU 12ml Keratin 14 0.1mL Keratin 8 1mL Dewax and HIER Buffer L(15x concentrate) 10x100mL Cyclin D1 / Bcl-1 [SP4] RTU 7ml p21 WAF1 1mL DOG-1 [SP31] 1mL Smooth Muscle Myosin HeavyChain 1mL (SMMHC) [EPR5336(B)] MSH6 [EPR3945] RTU 7 mL c-erbB-2 / HER-2 / neu [SP3] RTU 7ml ASR CD3epsilon RTU 7ml CD3 (Early T Cell Marker) 0.1mL Factor XIII A 0.5mL Keratin 5 RTU 12ml Protein Gene Product 9.5 RTU 7ml CD21 RTU 12ml Progesterone Receptor[hPRa 2+hPR 3] 1mL ASR Tris-HCl Buffer for HIER (10X) 50mL GCDFP-15 (Gross Cystic Disease Fluid Protein-15) 1mL UltraVision Anti-Polyvalent, HRP/DAB (RTU) 15mL UltraVision Protein Block 60ml Granzyme B 0.5mL CD23 1mL CD117 / c-Kit / SCF-Receptor 0.5mL c-erbB2 / HER-2 / neu [EP1045Y] 1mL ASR Estrogen Receptor [1D5] 1mL ASR CD45RO (T-Cell Marker) 0.1mL Progesterone Receptor [YR85]RTU 7ml ASR Epidermal Growth Factor Receptor (EGFR) [EP38Y] RTU 7ml UltraVision LP Large Vol HRP Polymer (RTU) 60mL CD20 0.1mL Ki-67 [SP6] 0.5mL Keratin 20 RTU 12ml p53 RTU 12ml CD20 [EP459Y] RTU 7ml CD57 (Natural Killer Cell Marker) 1mL p53 Ab-5 RTU 7ml Vimentin Ab-2 0.1mL MSH6 [EPR3945] RTU 12 mL CD5 RTU 7ml CD15 RTU 12ml Keratin, Low Molecular Weight 0.5mL Lysozyme / Muramidase 0.5mL MLH1 [4C9C7] RTU 7 mL Calcitonin 1mL MV Polymer/ anti-mouse/HRP+anti Rabbit/AP RTU 12ml p53 [SP5] RTU 7ml CD79a / mb-1 (B Cell Marker) 1mL Hepatocyte 0.1mL Troponin T,Cardiac Isoform 1ml CD45 / T200 / LCA 0.5mL ALK (Anaplastic Lymphoma Kinase) p80 RTU 12ml DOG-1 1mL S100 Protein 0.1mL CD21 1mL Keratin 17 RTU 7ml CD7 [EPR4242] 1 mL Hepatitis B Virus Surface Antigen (HBVsAg) 1mL ASR Placental Alk. Phosphatase (PLAP) RTU 7ml IgG (gamma-Heavy Chain) 0.1mL Helicobacter pylori RTU 12ml ASR Keratin, Low Molecular Weight 0.1mL Hepatitis B Virus Surface Antigen (HBVsAg) 0.1mL ASR Myelin Basic Protein 1mL Myelin Basic Protein Ab-1 0.5mL IgA (alpha-Heavy Chain) RTU 7ml BCL-6 [LN22] RTU 12ml UltraVision Quanto Detection System HRP 1L Placental Alk. Phosphatase (PLAP) Ab-4 0.5mL CD99 / MIC2 (Ewings Sarcoma Marker) 0.5mL Helicobacter pylori 1mL ASR Ki-67 [SP6] 1mL Vimentin-gp100 Tris-HCl Buffer for HIER (10X) 125mL CD44 Std. / HCAM 0.5mL Epithelial Specific Antigen (Ep-CAM) Ab-9 0.1mL Granzyme B RTU 7ml Keratin, Pan 0.1mL Vascular Endothelial Growth Factor (VEGF) 0.5mL ASR Prostate Specific Membrane Antigen (PSMA) [SP29] 0.1mL Adrenocorticotrophic Hormone (ACTH) 0.5mL Neurofilament (200kDa & 68kDa) 0.5mL Prostate Specific MembraneAntigen (PSMA) [SP29] RTU 12ml UV Hydrogen Peroxide Block 1L CD30 (Reed-Sternberg Cell Marker) Ab-1 RTU 7ml Desmin (Muscle Cell Marker) Ab-1 RTU 7ml Actin, Muscle Specific RTU 7ml CD8 Ab-1 0.5mL Kappa Light Chain Ab-2 RTU 12ml CD30 (Reed-Sternberg Cell Marker) Ab-1 0.5mL UV Hydrogen Peroxide Block60ml Tyrosinase 1mL Villin 0.5mL Lambda Light Chain Ab-2 RTU 7ml Fast-Red Substrate System 125mL Antibody Diluent OP Quanto Villin RTU 12ml Caldesmon, HMW 0.1mL Keratin 20 0.5mL CD68 / Macrophage Marker Ab-4 0.1mL Mucin 2 (MUC-2) 0.1mL Perforin 1mL p21 WAF1 0.5mL Beta-catenin 0.1mL Cyclin D1 / Bcl-1 [SP4] 1mL Helicobacter pylori 0.1mL ASR CD3epsilon (Early T-Cell Marker) 1mL p53 Ab-8 RTU 7ml ALK (Anaplastic Lymphoma Kinase) / p80 1mL CD8 [SP16] 1mL Lambda Light Chain Ab-2 0.5mL p57 Kip2 Ab-6 0.1mL Lambda Light Chain Ab-2 1mL PT Module Deparaffin. and HIER Solution (100X) pH6 125mL GCDFP-15 (Gross Cystic Disease Fluid Protein-15) RTU 7ml p504S/ AMACR [13H4] 1mL ASR S100 Protein 1mL Mucin 2 (MUC-2) 0.5mL c-erbB-2 / HER-2 / neu Ab-17 0.1mL ASR Mucin 2 (MUC-2) 1mL CD1a 1mL UltraVision Quanto DetectionSystem HRP DAB 60mL Mesothelioma RTU 12ml CD30 (Reed-Sternberg Cell Marker) Ab-4 0.1mL Smooth Muscle Myosin HeavyChain RTU 7ml [EPR5336(B)] RTU p53 [SP5] RTU 12ml Anti-Glial Fibrillary AcidicProtein (GFAP) [EP13] RTU 12ml Napsin-A [EPR6252] RTU 12 mL Progesterone Receptor [YR85]1mL ASR UltraVision LP Large Vol AP Polymer (RTU) 60mL Amyloid Precursor Protein (APP) 0.1mL Epithelial Specific Antigen (Ep-CAM) Ab-9 0.5mL S100 Protein 0.5mL Calponin-1 RTU 7ml IgA (alpha-Heavy Chain) 0.5mL Ki-67 [SP6] RTU 12ml Pax-5 0.1mL Actin, Muscle Specific 0.1mL Epstein-Barr Virus / LMP RTU 7ml ASR Smooth Muscle Myosin HeavyChain 1mL [EPR5336(B)] RTU CD99 / MIC2 (Ewings Sarcoma Marker) RTU 7ml Epithelial Specific Antigen (Ep-CAM) Ab-1 RTU 7ml Chromogranin A [SP12] 0.5mL Calretinin [SP13] RTU 12ml Calretinin [SP13] RTU 7ml p120 Catenin [EP66] RTU 7ml Factor XIII A 0.1mL S100 Protein RTU 7ml Hepatitis B Virus Surface Antigen (HBVsAg) 0.5mL ASR Ki-67 [SP6] 0.1mL FITC Protein Blocking Agent (PBA) 6mL Anti-Factor XIII A [EP3372] 0.1mL Kappa Light Chain Ab-1 0.1mL CD23 RTU 7ml UltraVision Anti-Polyvalent, AP/Fast Red (RTU) 15mL CD23 [SP23] RTU 12ml CD21 0.5mL Calretinin [SP13] 0.1mL CD20 [EP459Y] RTU 12ml c-erbB-2 / HER-2 / neu Ab-17 0.5mL ASR TdT / Terminal Deoxyribonucleotidyl Transferase 0.1mL Pax-5 1mL Keratin 19 0.1mL Myelin Basic Protein Ab-1 0.1mL Hepatitis B Virus SurfaceAntigen (HBVsAg) RTU 12mL ASR CD68 / Macrophage Marker Ab-4 0.5mL BCL-6 [LN22] 1mL IgM (mu-Heavy Chain) 1mL Progesterone Receptor[hPRa 2+hPR 3] 0.5mL ASR CD44 Std. / HCAM RTU 7ml CD57 (Natural Killer Cell Marker) 0.1mL OCT3/4 (POU5F1) [653108] RTU 7 mL Caldesmon, HMW RTU 7ml Melanoma (gp100) 1mL Macrophage / L1 Protein / Calprotectin 0.5mL p53 1mL Perforin RTU 7ml CD68 / Macrophage Marker Ab-3 RTU 7ml Pax-5 [SP34] RTU 12ml p53 [SP5] 0.1mL HIER Buffer M, 9 BT/CSEDTA Buffer,15ml/BT anti-glial fibrillary acidicprotein (GFAP) [EP13] RTU 1mL Tyrosinase 0.5mL Lysozyme / Muramidase 1mL PSA [EP1588Y] 0.1mL ASR Mucin 5AC (MUC-5AC) / Gastric Mucin 0.5mL Calcitonin 0.1mL Desmin (Muscle Cell Marker) Ab-1 0.1mL Neurofilament (200kDa & 68kDa) 0.1mL CA 125 (Ovarian Cancer Antigen) RTU 7ml UltraVision Quanto DetectionSystem AP 125mL CD68 / Macrophage Marker Ab-3 1mL Serotonin 1mL Epidermal Growth Factor Receptor (EGFR) [EP38Y] RTU 12ml Actin, Smooth Muscle 0.5mL p53 [SP5] 0.5mL DOG-1 [SP31] 0.1mL Phosphate Buffered Saline (10X) 10mL Vimentin Ab-2 1mL p57 Kip2 Ab-6 RTU 12ml CD105 / Endoglin / TGF beta 1/3 Receptor 0.1mL Keratin 8/18 Ab-1 RTU 12ml ZAP-70 [2F3.2] 1mL Keratin 17 1mL Beta-catenin RTU 7ml IgE (epsilon-Heavy Chain) 0.5mL Lambda Light Chain Ab-2 RTU 12ml p53 [SP5] 1mL Androgen Receptor RTU 7ml CD15 RTU 7ml Streptavidin Peroxidase (RTU) 60mL p504S/ AMACR [13H4] RTU 7mL ASR Keratin, Pan 1mL Epithelial Specific Antigen (Ep-CAM) Ab-9 RTU 7ml p504S/ AMACR [13H4] RTU 12mL ASR PT Module Deparaffin. and HIER Solution (100X) pH9 250mL GLUT-1 0.1mL OCT3/4 (POU5F1) [653108] 0.1mL CD7 [EPR4242] RTU 7 mL Mesothelin 1mL Epithelial Membrane Antigen / EMA RTU 12ml CD56 / NCAM-1 RTU 7ml Amyloid Precursor Protein (APP) RTU 7ml CD31 / PECAM-1 (EndothelialCell Marker) RTU 12ml CD1a RTU 12ml UltraVision ONE Large Vol, HRP Polymer (RTU) 125mL anti-glial fibrillary acidicprotein (GFAP) [EP13] 1mL NY-BR-1 RTU 7ml CD45 / T200 / LCA 1mL Renal Cell Carcinoma Marker (gp200) RTU 7ml Glycophorin A RTU 7ml Mucin 1 (MUC-1) 0.5mL Tartrate Resistant Acid Phosphatase (TRAP)Ab-1 RTU 7ml Renal Cell Carcinoma Marker (gp200) 0.5mL Pax-5 RTU 7ml S100 RTU 7ml BCL-6 [LN22] 0.1mL ZAP-70 [2F3.2] 0.1mL Placental Alk. Phosphatase (PLAP) 1mL Calretinin 1mL CD4 1mL Keratin 20 0.1mL Lambda Light Chain Ab-1 RTU 7ml GLUT-1 0.5mL p504S/ AMACR [13H4] 0.5mL ASR Fascin RTU 12ml UltraVision ONE Large Vol. AP Polymer (RTU) 125mL Chromogranin A RTU 7ml Keratin 14 0.5mL Epstein-Barr Virus / LMP 0.1mL ASR Smooth Muscle Myosin HeavyChain RTU 12ml [EPR5336(B)] RTU Placental Lactogen (hPL) RTURTU 7ml CD20 0.5mL Fascin 0.5mL CD99 / MIC2 (Ewings Sarcoma Marker) 0.1mL CD44 Std. / HCAM 0.1mL UltraVision Large Vol Anti-Polyvalent, HRP (RTU) 60mL Thyroid Transcription Factor-1 (TTF-1) 0.1mL CD79a / mb-1 (B Cell Marker) RTU 7ml Progesterone Receptor[hPRa 2+hPR 3] RTU 7ml ASR NY-BR-1 RTU 12ml D2-40 [D2-40] 1mL Progesterone Receptor [YR85]RTU 12ml ASR p57 Kip2 Ab-3 1mL Chromogranin A 1mL Keratin 20 RTU 7ml IgA (alpha-Heavy Chain) 0.1mL CD3 (Early T Cell Marker) 1mL Calponin-1 0.1mL CD5 [EP2952] 0.1mL Thyroid Transcription Factor-1 (TTF-1) 0.5mL CD20 Ab-1 1mL Keratin 18 RTU 7ml p57 Kip2 Ab-6 RTU 7ml MV Polymer/ anti-mouse/AP+anti Rabbit/HRP RTU 12ml CD79a / mb-1 (B-Cell Marker) [SP18] RTU 12ml NY-BR-1 1mL Keratin 18 Ab-1 RTU 7ml Chromogranin A [SP12] 0.1mL CD68 / Macrophage Marker Ab-4 1mL Beta-catenin RTU 12ml Desmin (Muscle Cell Marker) RTU 7ml CA19-9 Sialyl Lewis a GI Tumor Marker 1mL Keratin, HMW Ab-3 0.1mL Desmin (Muscle Cell Marker) 0.1mL Kappa Light Chain Ab-2 0.5mL IgE (epsilon-Heavy Chain) 0.1mL CD3epsilon 0.1mL Progesterone Receptor[hPRa 2+hPR 3] 0.1mL ASR Keratin 5 / 6 RTU 12ml Myelin Basic Protein 0.5mL CD20 Ab-1 RTU 7ml Factor VIII Related Antigen / von Willebrand Factor Ab-1 1mL Chromogranin A 0.5mL CD30 (Reed-Sternberg CellMarker) Ab-1 RTU 12ml GLUT-1 1mL Synaptophysin (Neuroendocrine Marker) 0.1mL Keratin 18 Ab-1 1mL Myelin Basic Protein Ab-1 RTU 12ml Factor VIII Related Antigen /von Willebrand Factor Ab-2 RTU 12ml UltraVision LP HRP Polymer & DAB Plus Chromogen 125mL Epithelial Specific Antigen (Ep-CAM) Ab-9 1mL CD1a 0.5mL CD45 / T200 / LCA RTU 12ml c-erbB-2 / HER-2 / neu [SP3] RTU 12ml ASR BOB1 [SP92] 1 mL p57 Kip2 Ab-6 0.5mL UltraVision Quanto HRP DAB 1L CD45 / T200 / LCA RTU 7ml CD117 / c-Kit / SCF-Receptor 0.1mL CD5 1mL IgD (delta-Heavy Chain) 1mL CD3epsilon 1mL p53 0.1mL Mucin 2 (MUC-2) RTU 12ml ZAP-70 [2F3.2] RTU 7ml UltraVision Quanto DetectionSystem HRP DAB Sample 15mL CD15 0.5mL Vascular Endothelial Growth Factor (VEGF) 1mL ASR Thyroid Stimulating Hormone (TSH) 0.1mL Streptavidin Peroxidase (RTU) B2:B1018 125mL GFAP / Glial Fibrillary Acidic Protein 0.1mL CD74 1mL Tubulin-Alpha 1mL CD8 0.5mL Claudin 4 RTU 7ml Thyroid Stimulating Hormone (TSH) 1mL Thyroid Stimulating Hormone (TSH) 0.5mL Claudin 3 RTU 7ml Insulin (INS04 + INS05) RTU 7ml CD8 0.1mL Thyroid Stimulating Hormone (TSH) RTU 7ml CD74 0.5mL Tubulin-Beta 0.5mL Tubulin-Beta 1mL Granulocyte (Myeloid cell Marker) RTU 7ml CD8 RTU 7ml CD74 RTU 7ml Claudin 3 0.5mL p57 Kip2 Ab-3 0.1mL Insulin (INS04 + INS05) 0.5mL Keratin, HMW Ab-1 1mL Tubulin-Alpha RTU 7ml Granulocyte (Myeloid cell Marker) 0.1mL Insulin (INS04 + INS05) 0.1mL Claudin 3 0.1mL Claudin 4 0.1mL p57 Kip2 Ab-3 0.5mL Keratin 8 / 18 0.1mL Insulin (INS04 + INS05) 1mL CD74 0.1mL Tubulin-Beta 0.1mL Claudin 4 0.5mL Keratin, HMW Ab-1 0.5mL Tubulin-Beta RTU 7ml GFAP / Glial Fibrillary Acidic Protein 1mL Claudin 4 1mL Tubulin-Alpha 0.5mL Keratin, HMW Ab-1 RTU 7ml Granulocyte (Myeloid cell Marker) 1mL Granulocyte (Myeloid cell Marker) 0.5mL CD8 1mL GFAP / Glial Fibrillary Acidic Protein 0.5 mL GFAP / Glial Fibrillary Acidic Protein RTU 7ml Keratin, HMW Ab-1 0.1mL Tubulin-Alpha 0.1mL Claudin 3 1mL QMS® Zonisamide Assay QMS Tacrolimus Calibrators RabMAb Anti-PR DRI Total Thyroxine T4 Calibrator CEDIA Cyclosporine Plus High Range Calibrator Acrometrix Oncology Hotspot Control Acrometrix Multi-Analyte Control HIV/HCV/HBV High Acrometrix Triscreen Acrometrix Multi-Analyte Control HIV/HCV/HBV Low Acrometrix CT/NG Control MAS Omni Infectious BSI Positive Control Panel MAS anti-HBs Positive Control MAS Infectious Negative Control MAS Syphilis Positive Control MAS HIV p24 Positive Control MAS anti-HBs Positive Control for use with Siemens Assays MAS Omni Infectious BSI Positive Control Panel for Use with Siemens Assays CEDIA Buprenorphine II Assay QMS Lidocaine CEDIA Multi-Drug Calibrators Siemens Dimension Vista Drug 2 Calibrator CEDIA Negative Calibrator Alinity c DOA MC Qual Calibrator 2 Kit Alinity c DOA MC Semiquant Calibrator Kit DRI Multi-Drug Urine Calibrators Alinity c Tox Qual Calibrators Siemens Atellica CH Drug II Cal Siemens ADVIA Chemistry Negative Drug Urine Calibrator DRI Drugs of Abuse Low Calibrator DRI Drugs of Abuse High Calibrator Alinity c TDM Multiconstituent Calibrator Kit Siemens Dimension Drug Cal II Alinity c DOA MC Qual Low Calibrator 1 Kit Siemens ADVIA Chemistry Serum Toxicology Calibrators Alinity c Benzodiazepines Semiquant Calibrator Kit DRI Negative Urine Calibrator CEDIA AntibioticTDM Multi-Calibrator CEDIA Multi-Drug OFT Calibrators Alinity c DOA MC Negative Calibrator Kit DRI Serum Tox Cals Siemens ADVIA Chemistry DRUG Calibrator II Alinity c Tox Semiquant Calibrators CEDIA Antibiotic TDM Multi-Cal Alinity c Benzodiazepines Qual Calibrator Kit CEDIA Carbamazepine II Assay QMS Gentamicin Alinity c Barbiturates Reagent Kit Multigent Barbiturates Assay for use with Architect DRI® Barbiturate Assay CEDIA Cannibinoids OFT Assay CEDIA Digitoxin Assay RabMAb Anti-ER Tricyclic Antidepressant CEDIA Cocaine OFT Assay Multigent Gentamicin Alinity C Gentamicin Reagent Kit QMS Everolimus Assay CEDIA Opiate OFT Assay DRI Methadone Metabolite Assay Siemens ADVIA® Chemistry Methadone Metabolite CEDIA DAU Opiate Assay MULTIGENT Gentamicin Calibrators for Architect Siemens Dimension DOA-Positive Control Siemens Dimension Vista Drugs of Abuse Positive Control Siemens Dimension Vista Drugs of Abuse Negative Control Siemens Dimension DOA-Negative Control CEDIA Heroin Metabolite (6-AM) Assay CEDIA Opiate 2K Assay CEDIA T4 CEDIA Barbiturates QMS® Tobramycin Reagents Multigent Tobramycin Reagents Alinity c Tobramycin Reagent Kit DRI Propoxyphene Assay MULTIGENT Propoxyphene Assay Alinity c Propoxyphene Reagent Kit MULTIGENT DOA MC I Controls MULTIGENT Opiates Low Ctrl Set MULTIGENT DOA MC II Controls Siemens Attelica CH Multidrug QC MULTIGENT DOA MC III Controls Siemens ADVIA® Chemistry Multi-Drug Urine Controls CEDIA Gentamicin II Assay CEDIA Gentamicin II Assay (GENTC) CEDIA LSD Assay CEDIA Phenobarbital II Assay MAS OmniIMMUNE PRO Max MAS Liquimmune Control Alinity iSTAT CK-MB Control Kit MAS Alcohol Ammonia Control MAS Omni-Core MAS Omni-Immune MAS ChemTRAK H MAS Immunology Control MAS Omni-Immune Pro MAS CardioImmune XL MAS Omni-Cardio MAS CSF Control Alinity i STAT Myoglobin Controls MAS T-Marker MAS OmniCORE Max MAS OmniIMMUNE Max MAS Immunology Advanced MAS Alcohol/Ammonia Max, Multi-Pack MAS Omni-Core II CRP (C-Reactive Protein) MAS Alcohol/Ammonia Max, Sample-Pack CEDIA Methadone Assay Alinity c Ethanol Calibrator Kit DRI Alcohol Calibrators QMS Everolimus Calibrator DRI Methadone Metabolite 300ng/mL Calibrator CEDIA Heroin Metabolite (6-AM) Cutoff Calibrator CEDIA Buprenorphine II Calibrators CEDIA PPX/Methadone Cutoff Calibrator DRI Hydrocodone Assay Calibrator 100 DRI Hydrocodone Assay Calibrator 300 CEDIA LSD Calibrators DRI Ecstasy Calibrators CEDIA Buprenorphine Calibrators DRI Methadone Metabolite 150ng/mL Calibrator DRI Oxycodone Calibrator 500 Alinity c Opiates Semiquant Calibrator Kit Alinity c Tobramycin Calibrators CEDIA Methamphetamine OFT Negative Calibrator DRI Hydrocodone Assay Calibrator 500 QMS Zonisamide Calibrator DRI THC Urine Calibrators CEDIA PPX/Methadone Intermediate Calibrator QMS Plazomicin Immunoassay Calibrator CEDIA Methamphetamine OFT Cut off Calibrator Alinity c Ecstasy Qual Calibrator Kit DRI Methadone Metabolite 2000ng/mL Calibrator CEDIA THC OFT Cutoff Calibrator Alinity c Cannabinoids Semiquant 200 Calibrator Kit DRI Hydrocodone Assay Calibrator 1000 QMS Lidocaine Calibrators QMS Vancomycin Calibrators CEDIA Heroin Metabolite (6-AM) High Calibrator CEDIA THC Calibrators CEDIA PPX/Methadone High Calibrator CEDIA THC OFT Negative Calibrator DRI Oxycodone Calibrator 1000 QMS Lamotrigine Calibrator QMS Gentamicin Calibrators QMS Amikacin Calibrator Multigent Quinidine Calibrators Alinity c Opiates Qual Calibrator Kit CEDIA Mycophenolic Acid Calibrators QMS Tobramycin Calibrators QMS Quinidine Calibrator Set DRI Methadone Metabolite 1000ng/mL Calibrator DRI Opiate Urine Calibrators DRI Oxycodone Calibrator 300 DRI Oxycodone Calibrator 100 DRI Oxycodone Calibrator 0 Alinity c Ecstasy Semiquant Calibrator Kit Alinity c Cannabinoids Semiquant 100 Calibrator Kit Alinity c Cannabinoids Qual Calibrator Kit Siemens Atellica MetMtb Cal Siemens ADVIA Chemistry Methadone Metabolite Urine Calibrators

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2006-01-13
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-12-10
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2008-08-06
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2006-01-13
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2021-10-19
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2008-02-27
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2013-11-13
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2014-11-05
KLQ	Radioimmunoassay, Amikacin	Clinical Toxicology	Class 2	862.3035	2007-11-28
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2018-11-13
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-04-03
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2007-11-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-11
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2018-05-16
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2014-11-05
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2014-05-21
OAV	Mycophenolic Acid Test System	Clinical Toxicology	Class 2	862.3840	2014-05-21
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2014-05-21
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2008-02-27
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2008-08-07
DKC	Alcohol Control Materials	Clinical Toxicology	Class 1	862.3280	2018-06-04
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2011-07-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2011-07-14
ORH	Lamotrigine Assay	Clinical Toxicology	Class 2	862.3350	2011-07-14
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2007-05-21
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	Clinical Chemistry	Class 2	862.1675	2011-07-28
NWM	Immunoassay, Anti-Seizure Drug	Clinical Toxicology	Class 2	862.3350	2011-07-14
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2006-01-13
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2008-02-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-02-27
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2015-02-24
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2008-02-27
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2006-01-13
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2018-07-31
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2009-12-21
LFW	Fluorescence Polarization Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2008-02-27
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2024-12-12
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2023-10-27
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-11-11
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2011-07-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-02-19
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2008-02-27
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Clinical Toxicology	Class 1	862.3220	2008-02-27
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-11-11
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2019-12-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-02-27
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2008-12-10
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-04-23
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Clinical Toxicology	Class 1	862.3220	2019-04-29
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2015-02-24
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2014-03-21
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-11-11
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2007-11-28
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2020-10-22
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2008-02-27
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2006-01-13
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2011-07-13
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2011-07-13
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-09-04
KXS	Radioimmunoassay, Methaqualone	Clinical Toxicology	Class 2	862.3630	2008-02-27
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2008-02-27
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2008-02-27
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-11-01
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2017-11-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-02-24
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-06-27
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2014-11-05
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2014-11-05
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2009-12-11
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2013-11-13
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2024-05-08
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-02-27
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2003-07-03
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2006-01-24
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2006-01-24
NWM	Immunoassay, Anti-Seizure Drug	Clinical Toxicology	Class 2	862.3350	2006-01-24
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-04-11
MXZ	Immunohistochemistry Assay, Antibody, Progesterone Receptor	Hematology	Class 2	864.1860	2007-11-12
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-04-23
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2015-03-10
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2017-04-11
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2017-04-11
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-04-11
KLR	Enzyme Immunoassay, Lidocaine	Clinical Toxicology	Class 2	862.3555	2011-07-14
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2018-09-24
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2008-02-27
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2011-07-14
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2012-11-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2011-07-13
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2011-07-13
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2008-02-27
MYA	Immunohistochemistry Antibody Assay, Estrogen Receptor	Hematology	Class 2	864.1860	2007-11-12
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2008-02-27
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2011-07-13
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2008-08-07
OUF	Everolimus Immunoassay	Clinical Toxicology	Class 2	862.3840	2013-09-16
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2011-07-13
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2008-02-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2008-02-26
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2013-09-04
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-09-04
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2008-08-07
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2014-11-11
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2023-10-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2014-11-05
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2016-01-11
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2016-01-11
LCR	Fluorescent Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2007-11-28
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2008-08-06
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2006-01-13
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2008-02-27
DLB	Radioimmunoassay, Lsd (125-I)	Clinical Toxicology	Class 2	862.3580	2008-02-27
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2008-02-27
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2019-04-10
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2014-11-05
DNN	Calibrators, Ethyl Alcohol	Clinical Toxicology	Class 2	862.3200	2018-06-04
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2018-09-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Thermo Fisher Scientific

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010455511	Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd	Suzhou Jiangsu, CN
3006190736	LABOMEX MBP	TIJUANA Baja California, MX
2517925	FISHER SCIENTIFIC COMPANY L.L.C.	PITTSBURGH, PA, US
3006440892	OXOID AUSTRALIA PTY LIMITED	THEBARTON South Australia, AU
1314344	Nalge Nunc International Corporation	Rochester, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153050	Co-Innovation Biotech Co., Ltd.	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	2016-04-26
K151478	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo CR3 Keyless Split Sample Cup	2015-07-01
K150179	Guangzhou Wondfo Biotech Co., Ltd.	CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids	2015-02-25
K112310	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHADONE URINE TEST,OPIATE TEST	2011-09-08
K093175	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES	2010-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2017	Microgenics Corporation	2	Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.
Z-0015-2008	Thermo Fisher Scientific	1	Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Z-0030-2013	Siemens Healthcare Diagnostics, Inc.	2	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Z-0029-2013	Alere San Diego, Inc.	2	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010939897. Last updated year: 2026. Please use registration number 3010939897 when referencing this establishment in official correspondence.