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 identification of hav-susceptible individuals for vaccination. Hav total quality control materials indication for use: for monitoring the performance of the hav total assay on advia centaur systems. The performance of the hav total quality control material has not been established with any other anti-hav total assay.
| Device | ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS |
| Classification Name | Hepatitis A Test (antibody And Igm Antibody) |
| Generic Name | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | BAYER HEALTHCARE, DIAGNOSTICS DIVISION |
| Date Received | 2004-04-01 |
| Decision Date | 2005-03-07 |
| Notice Date | 2005-03-21 |
| PMA | P040017 |
| Supplement | S |
| Product Code | LOL |
| Docket Number | 05M-0110 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAYER HEALTHCARE, DIAGNOSTICS DIVISION 511 Benedict Ave. tarrytown, NY 10591 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040017 | | Original Filing |
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NIH GUDID Devices