FDA Registration
Active
🇺🇸 United States
ADVIA Centaur
Reg #: 2432235
·
FEI: 2432235
·
Expires 2025
Products
41
Proprietary Names
2
Establishment Types
2
Classifications
41
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Inc.
- Registration Number
- 2432235
- FEI Number
- 2432235
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 511 Benedict Ave
- City
- Tarrytown
- State
- NY
- ZIP
- 10591
- Country
- US
Regulatory Submissions
- 510(k) Number
- K032525
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
- Correspondent
- Mary Seeger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2008-01-02 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2008-01-02 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2008-01-02 |
| Device, General Purpose, Hematology | LOQ | Class 2 | Immunology | No | 2008-01-02 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2008-01-02 |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | Class 2 | Immunology | No | 2008-01-02 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2008-01-02 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Ige, Antigen, Antiserum, Control | DGC | Class 2 | Immunology | No | 2008-01-02 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2008-01-02 |
| Fluorescence Polarization Immunoassay, Theophylline | LGS | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Fluorometric, Cortisol | JFT | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Enzyme Immunoassay, Digitoxin | LFM | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | LGR | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2008-01-02 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2008-01-02 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2008-01-02 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2008-01-02 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Fluorescent Immunoassay, Tobramycin | LCR | Class 2 | Clinical Toxicology | No | 2008-01-02 |
| Urinary Homocystine (Nonquantitative) Test System | LPS | Class 2 | Clinical Chemistry | No | 2008-01-02 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2008-01-02 |
Proprietary Names
ADVIA Centaur
Analyzer, ADVIA Centaur Classic
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility