PMA
P160016: VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)
FDA PMA · Assay, genotyping, hepatitis c virus · Fujirebio Europe N.V.
Key facts
| PMA number | P160016 |
|---|---|
| Trade name | VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA) |
| Generic name | Assay, genotyping, hepatitis c virus |
| Applicant | Fujirebio Europe N.V. |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | OBF |
| Approval date | Mar 14, 2017 |
| Docket number | 17M-1713 |
| Notice date | Apr 21, 2017 |
| Establishment registration | 2517506 |
| FEI number | 2517506 |
At a glance
- 1–9 Supplements
- Sep 23, 2020 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: