PMA
P100001: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
FDA PMA · Qualitative and Quantitative Hepatitis B Virus Antibody assays · Ortho-Clinical Diagnostics
Key facts
| PMA number | P100001 |
|---|---|
| Trade name | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS |
| Generic name | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
| Applicant | Ortho-Clinical Diagnostics |
| Owner/operator | QuidelOrtho Corporation |
| Product code | SEI |
| Approval date | Jul 20, 2011 |
| Docket number | 11M-0563 |
| Notice date | Aug 1, 2011 |
| Establishment registration | 3007111389 |
| FEI number | 3007111389 |
At a glance
- 10–99 Supplements
- Jan 24, 2023 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- No Withdrawn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: