PMA supplement
P080027 S001: ORAQUICK HCV RAPID ANTIBODY TEST
FDA PMA supplement · Panel Track · OraSure Technologies, Inc.
Key facts
| Original PMA | P080027 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ORAQUICK HCV RAPID ANTIBODY TEST |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | OraSure Technologies, Inc. |
| Product code | MZO |
| Received date | Aug 3, 2010 |
| Decision date | Feb 18, 2011 |
| Docket number | 11M-0132 |
| Notice date | Mar 9, 2011 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: