Approval for the advia centaur hav igm. Hav igm readypack reagents: this device is indicated for use for the advia centaur hav igm assay and is an in vitro diagnostic immunoassay for the qualitative determination of igm response to the hepatitis a virus (hav) in human serum or plasma (potassium edta, lithium or sodium heparinized) using the advia centaur system. The assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis a virus. Hav igm quality control materials: the controls are indicated for in vitro diagnostic use in monitoring the performance of the hav igm assay on the advia centaur systems. The performance of the hav igm quality control material has not been established with any other anti-hav igm assays.
| Device | ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS |
| Classification Name | Hepatitis A Test (antibody And Igm Antibody) |
| Generic Name | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | BAYER HEALTHCARE, LLC |
| Date Received | 2004-04-01 |
| Decision Date | 2004-12-22 |
| Notice Date | 2005-04-12 |
| PMA | P040018 |
| Supplement | S |
| Product Code | LOL |
| Docket Number | 05M-0129 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAYER HEALTHCARE, LLC 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 |
|---|
| P040018 | | Original Filing |
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NIH GUDID Devices