PMA
P000014: VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · Ortho-Clinical Diagnostics, Inc.
Key facts
| PMA number | P000014 |
|---|---|
| Trade name | VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Owner/operator | QuidelOrtho Corporation |
| Product code | SEI |
| Approval date | Sep 29, 2000 |
| Docket number | 00M-1658 |
| Notice date | Dec 12, 2000 |
| Establishment registration | 1319681 |
| FEI number | 1000136573 |
At a glance
- 10–99 Supplements
- Oct 22, 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- No Withdrawn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: