ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS
FDA premarket approval P040017 · decided 2005-03-07
Approval details
- PMA number
- P040017
- Trade name
- ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Bayer Healthcare, Diagnostics Division
- Date received
- 2004-04-01
- Decision date
- 2005-03-07
- Days to decision
- 340 days
- Decision code
- APRL
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR THE ADVIA CENTAUR HAV TOTAL ASSAY AND QUALITY CONTROL MATERIALS. HAV TOTAL ASSAY INDICATION FOR USE: THE ADVIA CENTAUR HAV TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS A VIRUS (ANTI-HAV ) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THIS ANTI-HAV ASSAY IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION OR IN THE I
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE (K042015) | Bayer Healthcare, Diagnostics Division | 2004-09-29 |
| CO2 CALIBRATOR/DILUENT (K033643) | Bayer Healthcare, Diagnostics Division | 2004-01-08 |