PMA supplement
BP160122 S003: VITROS Immunodiagnostic Products HIV Combo Calibrator; VITROS Immunodiagnostic Products HIV Combo Reagent Pack
FDA PMA supplement · Normal 180 Day Track · Ortho-Clinical Diagnostics, In
Key facts
| Original PMA | BP160122 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track |
| 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 |
| Product code | MZF |
| Received date | Mar 1, 2018 |
| Decision date | Nov 1, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: