PMA
P090028: VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
FDA PMA · Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) · Ortho-Clinical Diagnostics, Inc.
Key facts
| PMA number | P090028 |
|---|---|
| Trade name | VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Owner/operator | QuidelOrtho Corporation |
| Product code | LOM |
| Approval date | May 11, 2011 |
| Docket number | 11M-0348 |
| Notice date | May 20, 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- No Withdrawn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: