PMA
P050042: ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
FDA PMA · Assay, enzyme linked immunosorbent, hepatitis c virus · Abbott Laboratories, Inc.
Key facts
| PMA number | P050042 |
|---|---|
| Trade name | ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Abbott Laboratories, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MZO |
| Approval date | Jun 7, 2006 |
| Docket number | 06M-0389 |
| Notice date | Sep 26, 2006 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Dec 15, 2021 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: