PMA
P010021: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
FDA PMA · Assay, enzyme linked immunosorbent, hepatitis c virus · Ortho-Clinical Diagnostics, Inc.
Key facts
| PMA number | P010021 |
|---|---|
| Trade name | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Owner/operator | QuidelOrtho Corporation |
| Product code | MZO |
| Approval date | Aug 30, 2001 |
| Docket number | 01M-0536 |
| Notice date | Dec 5, 2001 |
| Establishment registration | 3007111389 |
| FEI number | 3007111389 |
At a glance
- 10–99 Supplements
- Aug 7, 2020 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- No Withdrawn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: