PMA supplement
P030026 S016: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
FDA PMA supplement · Normal 180 Day Track · Ortho-Clinical Diagnostics, Inc.
Key facts
| Original PMA | P030026 |
|---|---|
| Supplement number | S016 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | LOM |
| Received date | Feb 20, 2009 |
| Decision date | Jul 15, 2009 |
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: