PMA
P040018: ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS
FDA PMA · Hepatitis a test (antibody and igm antibody) · Bayer Healthcare, LLC
Key facts
| PMA number | P040018 |
|---|---|
| Trade name | ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS |
| Generic name | Hepatitis a test (antibody and igm antibody) |
| Applicant | Bayer Healthcare, LLC |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | LOL |
| Approval date | Dec 22, 2004 |
| Docket number | 05M-0129 |
| Notice date | Apr 12, 2005 |
| Establishment registration | 2432235 |
| FEI number | 2432235 |
At a glance
- None Supplements
- Dec 22, 2004 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- No Withdrawn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: