PMA
P080027: ORAQUICK HCV RAPID ANTIBODY TEST
FDA PMA · Assay, enzyme linked immunosorbent, hepatitis c virus · OraSure Technologies, Inc.
Key facts
| PMA number | P080027 |
|---|---|
| Trade name | ORAQUICK HCV RAPID ANTIBODY TEST |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | OraSure Technologies, Inc. |
| Owner/operator | ORASURE TECHNOLOGIES, INC. |
| Product code | MZO |
| Approval date | Jun 25, 2010 |
| Docket number | 10M-0402 |
| Notice date | Jul 30, 2010 |
| Establishment registration | 3004142665 |
| FEI number | 3004142665 |
At a glance
- 10–99 Supplements
- Apr 20, 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- No Withdrawn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: