PMA
BP160122: VITROS Immunodiagnostic Products HIV Combo Calibrator; VITROS Immunodiagnostic Products HIV Combo Reagent Pack
FDA PMA · Hiv detection test · Ortho-Clinical Diagnostics, In
Key facts
| PMA number | BP160122 |
|---|---|
| Trade name | VITROS Immunodiagnostic Products HIV Combo Calibrator; VITROS Immunodiagnostic Products HIV Combo Reagent Pack |
| Generic name | Hiv detection test |
| Applicant | Ortho-Clinical Diagnostics, In |
| Owner/operator | QuidelOrtho Corporation |
| Product code | MZF |
| Approval date | Dec 13, 2017 |
| Establishment registration | 2250051 |
| FEI number | 2250051 |
At a glance
- 10–99 Supplements
- Sep 23, 2020 Latest supplement decision
- No Withdrawn
- No 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: