FDA Registration
Active
🇺🇸 United States
Siemens Healthcare Diagnostics Inc.
Reg #: 1219913
·
FEI: 1219913
·
Expires 2026
Products
96
Proprietary Names
417
Establishment Types
4
Classifications
96
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Inc.
- Registration Number
- 1219913
- FEI Number
- 1219913
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 333 Coney Street
- City
- E Walpole
- State
- MA
- ZIP
- 02032
- Country
- US
Regulatory Submissions
- 510(k) Number
- K010050
- PMA Number
- P030040
Owner / Operator
- Firm Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Operator Number
- 9096044
- Address
- Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Qualitative And Quantitative Hepatitis B Virus Antibody Assays | SEI | Class 2 | Microbiology | No | 2007-12-27 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2007-12-27 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2007-12-27 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2007-12-27 |
| Anti-Müllerian Hormone Test System | PQO | Class 2 | Clinical Chemistry | No | 2023-06-06 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2013-02-06 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2007-12-27 |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | Class 2 | Immunology | No | 2007-12-27 |
| Differential Rate Kinetic Method, Cpk Or Isoenzymes | JHS | Class 2 | Clinical Chemistry | No | 2007-12-27 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2007-12-27 |
| Antigen, Inflammatory Response Marker, Sepsis | NTM | Class 2 | Microbiology | No | 2015-03-27 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2007-12-28 |
| Counter (Beta, Gamma) For Clinical Use | JJJ | Class 1 | Clinical Chemistry | No | 1998-02-19 |
| Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | MTF | Class 3 | Unknown | No | 2015-05-06 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2007-12-27 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2007-12-27 |
| System, Test, Her-2/Neu, Monitoring | NCW | Class 2 | Immunology | No | 2007-12-27 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2011-06-29 |
| Radioimmunoassay, Total Thyroxine | CDX | Class 2 | Clinical Chemistry | No | 2007-12-28 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2007-12-27 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2012-11-08 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2017-09-14 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2007-12-27 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 1998-02-12 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2007-12-28 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2007-12-27 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2011-06-28 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2007-12-27 |
| Assayed Quality Control Material For Clinical Microbiology Assays | QCH | Class 2 | Microbiology | No | 2018-08-07 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2018-08-07 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 1998-02-12 |
| Bromcresol Purple Dye-Binding, Albumin | CJW | Class 2 | Clinical Chemistry | No | 2023-07-20 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2023-07-20 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 1995-04-18 |
| Zika Virus Serological Reagents | QFO | Class 2 | Microbiology | No | 2019-09-12 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2024-08-28 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 1998-06-16 |
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 1998-06-16 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 1998-06-16 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 1998-06-16 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 1998-06-16 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 1998-06-16 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 1998-06-16 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2011-06-28 |
| Cyclosporine | MKW | Class 2 | Clinical Chemistry | No | 2011-06-28 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 2006-08-04 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2007-12-27 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | JJC | Class 1 | Clinical Chemistry | No | 1998-02-19 |
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | Class 2 | Microbiology | No | 2007-12-27 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2007-12-28 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2017-06-05 |
| Ige, Antigen, Antiserum, Control | DGC | Class 2 | Immunology | No | 2007-12-28 |
| Antigen(Complexed),Prostate Specific,(Cpsa) | NAF | Class 3 | Unknown | No | 2007-12-27 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2007-12-28 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2007-12-28 |
| Antibody Igm,If, Cytomegalovirus Virus | LKQ | Class 2 | Microbiology | No | 2010-12-20 |
| Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | MTG | Class 3 | Unknown | No | 2007-12-28 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2007-12-28 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2023-08-02 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2007-12-28 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2019-07-02 |
| Cuvette, Thermostated | JRI | Class 1 | Clinical Chemistry | No | 1998-02-12 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2015-04-02 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2015-04-02 |
| Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | LOK | Class 3 | Unknown | No | 2014-05-21 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2026-01-06 |
| Immunochemical, Thyroglobulin Autoantibody | JNL | Class 2 | Immunology | No | 2026-01-06 |
| Hepatitis A Test (Antibody And Igm Antibody) | LOL | Class 2 | Microbiology | No | 2007-12-27 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2008-01-02 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2008-01-02 |
| Device, General Purpose, Hematology | LOQ | Class 2 | Immunology | No | 2008-01-02 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Fluorometric, Cortisol | JFT | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Fluorescence Polarization Immunoassay, Theophylline | LGS | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | LGR | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Fluorescent Immunoassay, Tobramycin | LCR | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2008-01-02 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2025-02-27 |
| Kit, Test,Alpha-Fetoprotein For Testicular Cancer | LOJ | Class 2 | Immunology | No | 2007-12-27 |
| Prognostic Test For Assessment Of Liver Related Disease Progression | QQB | Class 2 | Clinical Chemistry | No | 2021-09-17 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2012-02-03 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2008-01-18 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2008-01-18 |
| Chemiluminescent Immunoassay System | PKM | Class N | Unknown | No | 2015-04-17 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2021-05-25 |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | Class 2 | Microbiology | No | 2018-07-18 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 1998-02-12 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2008-01-09 |
| System, Test, Thyroglobulin | MSW | Class 2 | Immunology | No | 2025-09-03 |
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 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
Atellica IM Follicle Stimulating Hormone (FSH)
ADVIA Centaur Follicle Stimulating Hormone (FSH)
C-STIX
FOLATE
ASCORBIC ACID
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
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 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 Intact PTH IPTH)
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
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
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)
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 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)
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)
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 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)
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
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)
Atellica IM T3/T4/VB12 Ancillary Reagent
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)
ADVIA Centaur CA 15-3 (CA15-3)
Atellica IM CA 15-3 Calibrator (CA15-3 CAL)
Atellica IM CA 15-3 (CA15-3)
Atellica IM CA 15-3 Master Curve Material Set (CA 15-3 MCM)
Atellica IM Enhanced Liver Fibrosis Calibrator (ELF CAL)
Atellica IM HA (HA)
Atellica IM PIIINP (PIIINP)
Atellica IM TIMP-1 (TIMP-1)
ADVIA Centaur Enhanced Liver Fibrosis Calibrator (ELF CAL)
ADVIA Centaur HIV Ag/Ab Combo Quality Control Kit (CHIV QC)
ADVIA Centaur HIV Ag/Ab Combo (CHIV)
Atellica IM HIV Ag/Ab Combo Quality Control Kit (CHIV QC)
ADVIA Centaur Progesterone Master Curve Material (PRGE MCM)
Atellica IM Ferritin Master Curve Material (FER MCM)
Atellica IM Progesterone Master Curve Material (PRGE MCM)
ADVIA Centaur Ferritin Master Curve Material (FER MCM)
ADVIA Centaur Cortisol Master Curve Material (Cor MCM)
ADVIA Centaur Cortisol Urine Reconstitution Buffer (COR Recon Buf)
Atellica IM Cortisol Urine Reconstitution Buffer (COR Recon Buf)
Atellica IM Hepatitis A IgM Quality Control (aHAVM QC)
ADVIA Centaur Hepatitis A IgM Quality Control (aHAVM QC)
ADVIA Centaur Hepatitis B Surface Antigen II (HBsII)
Atellica IM Hepatitis B surface Antigen II Confirmatory (HBsII Conf)
Atellica IM Hepatitis B Surface Antigen II (HBsII)
Atellica IM Hepatitis B surface Antigen II Quality Control (HBsII QC)
Atellica IM Sample Inactivation Media
ADVIA Centaur TSH3-Ultra II (TSH3ULII)
Atellica IM free PSA II (tPSAII)
Atellica IM BRAHMS Procalcitonin (PCT)
Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC)
ADVIA Centaur Hepatitis B e Antigen Quality Control (HBeAg QC)
Atellica IM Hepatitis B e Antigen (HBeAg)
ADVIA Centaur Hepatitis B e Antigen (HBeAg)
ADVIA Centaur Sample Tips
SEPTUM CAPS
ADVIA Centaur Sample Cups
ADVIA Centaur Prolactin (PRL)
Atellica IM Prolactin (PRL)
ADVIA Centaur Intact PTH Master Curve Material (iPTH MCM)
ADVIA Centaur HBc Total 2 (HBcT2)
Atellica IM HBc Total 2 Quality Control (HBcT2 QC)
Atellica IM HBc Total 2 (HBcT2)
ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC)
ADVIA CENTAUR TOXOPLASM
Atellica IM Toxoplasma IgM (Toxo M)
Atellica IM Toxoplasma IgM Quality Control (Toxo M QC)
IMMULITE 2000 Folic Acid (FOL)
IMMULITE 2000 Folic Acid /Vitamin B12 Sample Diluent
IMMULITE Ascorbic Acid (Ascorbic Acid)
Atellica IM Folate Assay (FOL)
Atellica IM Folate Diluent (FOL DIL)
Atellica IM Folate RBC (Fol RBC)
Atellica IM Folate DTT/Releasing Agent (Fol DTT/REL)
ADVIA Centaur Anti-Thyroglobulin (aTG)
Atellica IM Calibrator 1 (Cal 1)
ADVIA Centaur Calibrator 1 (Cal 1)
Atellica IM aTG Quality Control (aTG QC)
ADVIA Centaur aTG Diluent (aTG Dil)
ADVIA Centaur aTG Quality Control (aTG QC)
Atellica IM aTG Diluent (aTG Dil)
Atellica IM Anti-Thyroglobulin (aTG)
Atellica IM Anti-Thyroglobulin Master Curve Material Set (aTG MCM)
ADVIA Chemistry
Atellica IM Vitamin D Total Quality Control (VitD QC)
Atellica IM Vitamin D Total Master Curve Material (VitD MCM)
Atellica IM Thyroglobulin (Tg)
Atellica IM Tg Master Curve Material (Tg MCM)
Atellica IM Total hCG (ThCG)
Atellica IM Total hCG Diluent (ThCG Dil)
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility