PMA
P040017: ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS
FDA PMA · Hepatitis a test (antibody and igm antibody) · Bayer Healthcare, Diagnostics Division
Key facts
| 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 |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | LOL |
| Approval date | Mar 7, 2005 |
| Docket number | 05M-0110 |
| Notice date | Mar 21, 2005 |
| Establishment registration | 2432235 |
| FEI number | 2432235 |
At a glance
- None Supplements
- Mar 7, 2005 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: