PMA
P030056: ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
FDA PMA · Assay, enzyme linked immunosorbent, hepatitis c virus · Siemens Healthcare Diagnostics
Key facts
| PMA number | P030056 |
|---|---|
| Trade name | ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Siemens Healthcare Diagnostics |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | MZO |
| Approval date | Dec 22, 2004 |
| Docket number | 05M-0478 |
| Notice date | Nov 28, 2005 |
| Establishment registration | 1219913 |
| FEI number | 1219913 |
At a glance
- 10–99 Supplements
- Apr 27, 2021 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- No Withdrawn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: