Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219913

FEI Number

1219913

Entity Name

Siemens Healthcare Diagnostics Inc.

City/State/Country

E Walpole, MA, US

Establishment Address

333 Coney Street, E Walpole, MA 02032, US

Establishment Type(s)

Manufacture Medical Device

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

Expiration Date (Year)

2026

510(k) Number

K171274

PMA Number

N/A

All Registered Proprietary Names

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) ADVIA Centaur Folate Master Curve Material (FOL MCM) ADVIA Centaur Folate (FOL) ADVIA Centaur DDT/Releasing Agent ADVIA Centaur Folate Diluent 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 DHEA-SO4 (DHEAS) Atellica IM DHEA-SO4 (DHEAS) Atellica IM DHEAS2 (DHEAS2) 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) 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) ADVIA Centaur BRAHMS PCT (PCT) ADVIA Centaur BRAHMS PCT Quality Control Material (PCT QC) ADVIA Centaur Atellica IM Toxoplasma IgG Quality Control (Toxo G QC) Atellica IM Toxoplasma IgG (Toxo G) 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 Hepatitis B surface Antigen Quality Control (HBs QC) ADVIA Centaur Hepatitis B surface Antigen Confirmatory (HBsAg Conf) GENESYS GAMMA COUNTE THYRIMETER DIRECT RATI ADVIA Centaur Prolactin Master Curve Material (PRL MCM) Atellica IM Prolactin Master Curve Material (PRL MCM) Atellica IM Free Prostate Specific Antigen (fPSA) ADVIA Centaur Free PSA (fPSA) Atellica IM Free Prostate Specific Antigen Calibrator (fPSA CAL) ADVIA Centaur Free PSA Calibrator (fPSA CAL) 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) ADVIA Centaur HER-2/neu (H2n) ADVIA Centaur HER-2/neu Calibrator (H2n Cal) Atellica IM HER-2/neu (H2n) ADVIA Centaur HER-2/neu 1,2 Quality Control Material (H2n QC) Atellica IM HER-2/neu Calibrator (H2n Cal) ADVIA Centaur HER-2/neu Master Curve Material (H2n MCM) Atellica IM HER-2/neu 1,2 Quality Control Material (H2n QC) 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 ADVIA Centaur Testosterone II Master Curve Material (TSTII MCM) Atellica IM Digoxin Master Curve Material (Dig MCM) ADVIA Centaur Luteinizing Hormone (LH) Atellica IM Luteinizing Hormone (LH) ADVIA Centaur Luteinizing Hormone Master Curve Material (LH 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) Atellica IM Ferritin Assay Atellica IM Calibrator 80 (CAL 80) ADVIA Centaur Calibrator 80 ADVIA Centaur Atellica IM Follicle Stimulating Hormone (FSH) ADVIA Centaur Follicle Stimulating Hormone (FSH) C-STIX FOLATE ASCORBIC ACID ADVIA Centaur 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) ADVIA Centaur TSH3-UL MCM ADVIA Centaur TSH3-Ultra II Master Curve Material (TSH3ULII) ADVIA Centaur Free Triiodothyronine (FT3) Atellica IM Free Triiodothyronine (FT3) ADVIA Centaur Free Triiodothyronine Master Curve Material (FT3 MCM) 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 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 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) 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 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 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 Atellica IM High-Sensitivity Troponin I (TnIH) Rapidpoint 400 Rapidpoint Blood Gas Blood Gas Systems Family ADVIA Centaur Atellica IM IMMULITE 2000 Androstenedione (AND) Vista LH Flex MAGIC LITE LH LUTEN 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) TECHNICON STAR SYSTEM MAGIC LITE ANALYZER ADVIA Centaur HCV Atellica IM aHCV ADVIA Centaur Vitamin B12 (VB12) Atellica IM Vitamin B12 DTT/Releasing Agent (VB12 DTT/REL) Atellica IM Vitamin B12 Diluent (VB12 DIL) Atellica IM Calibrator C (Cal C) ADVIA Centaur Vitamin B12 Diluent (VB12 DIL) ADVIA Centaur Vitamin B12 DTT/Releasing Agent (VB12 DTT/REL) Atellica IM Vitamin B12 (VB12) ADVIA Centaur Calibrator C (Cal C) ADVIA Centaur Vitamin B12 Master Curve Material (VB12 MCM) ADVIA Centaur ADVIA Centaur Intact Parathyroid Hormone (PTH) Master Curve ADVIA Centaur Intact Parathyroid Hormone (PTH) Quality Control ADVIA Centaur Intact Parathyroid Hormone (PTH) Atellica IM Intact Parathyroid Hormone Quality Control (PTH QC) Atellica IM Intact Parathyroid Hormone Master Curve Material (PTH MCM) Atellica IM Intact Parathyroid Hormone (PTH) ADVIA Centaur Intact Parathyroid Hormone (iPTH) ADVIA Centaur IgE Diluent (IgE Dil) Atellica IM total PSA II (tPSAII) 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) ADVIA Centaur ADVIA Centaur Intact PTH IPTH) ADVIA Centaur Atellica IM ADVIA Centaur Atellica IM Calibrator 30 (CAL 30) ADVIA Atellica IM Cyclosporine Master Curve Material (CsA MCM) ADVIA Centaur Cyclosporine Master Curve Material (CsA MCM) 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) ADVIA Centaur Prostate-specific Antigen (PSA) Atellica IM CAL Q Atellica IM Prostate-specific Antigen (PSA) ADVIA Centaur Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) ADVIA Centaur ThCG ADVIA Centaur ThCG Diluent ADVIA Centaur Atellica IM Rubella IgM Quality Control (Rub M QC) Atellica IM Rubella IgM (Rub M) ADVIA® Chemistry Toxicology Calibrators Dimension Drug Cal II Dimension Vista DRUG 2 Cal Dimension Vista TU Flex MAGIC LITE T UPTAKE REFERENCE SERUM ADVIA Centaur CUVETTES ADVIA Centaur Systems Cuvette 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 Dimension LOCI N-Terminal Pro-Brain Natriuretic Peptide Flex reagent cartridge Dimension Vista LOCI B-type Natriuretic Peptide Flex reagent cartridge ADVIA Centaur NT-proBNP (PBNP) Atellica IM NT-proBNP (PBNP) ADVIA Centaur ADVIA Centaur Atellica IM DHEA-SO4 Master Curve Material (DHEAS MCM) ADVIA Centaur DHEA-SO4 Master Curve Material (DHEAS MCM) 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) 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) Atellica IM total PSA II (tPSAII) Atellica IM Hepatitis A Total (HAVT) Atellica IM Hepatitis A Total Quality Control (HAVT QC) ADVIA Centaur Hepatitis A Total Quality Control (HAVT QC) ADVIA Centaur IgE Master Curve Material (IgE MCM) ADVIA Centaur Analyzer, ADVIA Centaur Classic 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) Atellica IM NT proBNPII (PBNPII) ADVIA Centaur NT proBNPII (PBNPII) Atellica IM HIV Ag/Ab Combo (CHIV) ADVIA Centaur® Testosterone II (TSTII) Atellica IM Testosterone II (TSTII) Atellica IM Sex Hormone Binding Globulin (SHBG) ADVIA Centaur Carcinoembryonic Antigen (CEA) Atellica IM Carcinoembryonic Antigen (CEA) ADVIA Centaur Atellica IM Rubella IgG Quality Control (Rub G QC) Atellica IM Rubella IgG (Rub G) ADVIA Centaur CA 15-3 III ADVIA Centaur CA 15-3 Calibrator (CA 15-3 CAL) 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) Atellica IM Enhanced Estradiol Master Curve Material (eE2 MCM) ADVIA Centaur Enhanced Estradiol Master Curve Material (eE2 MCM) ADVIA Centaur Alpha Fetoprotein Master Curve Material (AFP MCM) ADVIA Centaur Calibrator D 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) ADVIA Centaur Atellica IM aTPO MCM (aTPO MCM) ADVIA Centaur Anti-Thyroid Peroxidase (aTPO) Atellica IM Anti-Thyroid Peroxidase (aTPO) ADVIA Centaur aTPO QC (aTPO QC) Atellica IM aTPO QC (aTPO QC) Atellica IM Calibrator O (Cal O) Atellica IM aTPO Diluent (aTPO Dil) ADVIA Centaur aTPO Diluent (aTPO Dil) ADVIA Centaur Calibrator O (Cal O) ADVIA Centaur aTPO MCM (aTPO MCM) Atellica IM Calibrator E (CAL E) Atellica IM Progesterone (PRGE) ADVIA Centaur Calibrator E (CAL E) ADVIA Centaur Progesterone (PRGE) ADVIA Centaur Enhanced Liver Fibrosis (ELF) Atellica IM Enhanced Liver Fibrosis (ELF) Dimension FT3 Flex MAGIC LITE T3 100 TEST KIT IMMULITE 2000 Total T3 (T3) Dimension Vista FT3 Flex ADVIA Centaur Atellica IM Rapidlab 1200 Rapidlab Blood Gas Systems Rapidlab 800 Series Rapidlab 1200 Series ADVIA Centaur CA 125II (CA 125II) Atellica IM CA 125II (CA 125II) 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) ADVIA Centaur Atellica IM T3/T4/VB12 Ancillary Reagent 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) ADVIA Centaur High-Sensitivity Troponin I (TNIH)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-27
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	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
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2013-02-06
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
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
NTM	Antigen, Inflammatory Response Marker, Sepsis	Microbiology	Class 2	866.3210	2015-03-27
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2007-12-28
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
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2007-12-27
JJJ	Counter (Beta, Gamma) For Clinical Use	Clinical Chemistry	Class 1	862.2320	1998-02-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-01-07
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2015-05-06
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
NCW	System, Test, Her-2/Neu, Monitoring	Immunology	Class 2	866.6010	2007-12-27
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
CDX	Radioimmunoassay, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2007-12-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-04-11
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2007-12-27
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
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2017-09-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-11-08
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2007-12-27
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	1998-02-12
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2007-12-28
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2007-12-27
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2011-06-28
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2007-12-27
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
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	1998-02-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-07-18
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
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	1995-04-18
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
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2024-08-28
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	1998-06-16
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	1998-06-16
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	1998-06-16
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	1998-06-16
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	1998-06-16
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	1998-06-16
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	1998-06-16
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2011-06-28
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2011-06-28
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	Class 1	862.1075	2006-08-04
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1995-04-18
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2007-12-27
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	1998-02-19
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2007-12-27
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2007-12-28
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2008-01-09
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2017-06-05
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-28
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2026-03-06
NAF	Antigen(Complexed),Prostate Specific,(Cpsa)	Unknown	Class 3	N/A	2007-12-27
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2013-03-27
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
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-06-29
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-06-28
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
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
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2017-08-01
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2023-08-02
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2007-12-28
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2019-07-02
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	1998-03-12
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2008-01-03
JRI	Cuvette, Thermostated	Clinical Chemistry	Class 1	862.2050	1998-02-12
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
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2014-04-10
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-04-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-06-29
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	Unknown	Class 3	N/A	2014-05-21
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
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2026-03-06
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2007-12-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-03-20
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
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
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2024-01-25
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2025-02-27
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2019-10-22
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2026-05-19
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2007-12-28
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2007-12-27
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2007-12-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-06-29
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Immunology	Class 2	866.6010	2007-12-27
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2007-12-27
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
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2007-12-28
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-12-28
QQB	Prognostic Test For Assessment Of Liver Related Disease Progression	Clinical Chemistry	Class 2	862.1622	2021-09-17
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1998-02-24
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2012-02-03
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-01-18
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2008-01-18
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-01-18
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2008-01-18
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2008-01-18
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-01-18
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2008-01-18
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2008-01-18
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2026-05-19
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
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2007-12-28
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
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2018-08-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIEMENS HEALTHCARE DIAGNOSTICS INC.

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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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
Z-0102-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
Z-0103-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
Z-0113-2019	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Z-0114-2019	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Z-0115-2019	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Z-0115-2021	Siemens Healthcare Diagnostics, Inc	2	Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993, UDI Codes: (01)00630414471228(10)64661A48(17)20201112 (01)00630414471228(10)81211A48(17)20201112 (01)00630414471228(10)91743A48(17)20201112 (01)00630414471228(10)22124A49(17)20201211 Product Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.
Z-0116-2019	Siemens Healthcare Diagnostics, Inc	2	Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Z-0117-2019	Siemens Healthcare Diagnostics, Inc	2	Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Z-0124-2022	Siemens Healthcare Diagnostics, Inc	1	Atellica IM 1300 Analyzer, SMN 11066001
Z-0125-2022	Siemens Healthcare Diagnostics, Inc	1	Atellica IM 1600 Analyzer, SMN 11066000
Z-0128-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
Z-0129-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
Z-0130-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
Z-0162-2013	Siemens Healthcare Diagnostics, Inc	2	Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219913. Last updated year: 2026. Please use registration number 1219913 when referencing this establishment in official correspondence.