PMA supplement
P160016 S004: Versant HCV Genotype 2.0 Assay (LiPA)
FDA PMA supplement · 30-Day Notice · Fujirebio Europe N.V.
Key facts
| Original PMA | P160016 |
|---|---|
| Supplement number | S004 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Versant HCV Genotype 2.0 Assay (LiPA) |
| Generic name | Assay, genotyping, hepatitis c virus |
| Applicant | Fujirebio Europe N.V. |
| Product code | OBF |
| Received date | Jul 25, 2019 |
| Decision date | Sep 20, 2019 |
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: