PMA
P060030: COBAS AMPLIPREP/COBAS TAQMAN HCV TEST
FDA PMA · Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus · Roche Molecular Systems, Inc.
Key facts
| PMA number | P060030 |
|---|---|
| Trade name | COBAS AMPLIPREP/COBAS TAQMAN HCV TEST |
| Generic name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
| Applicant | Roche Molecular Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | MZP |
| Approval date | Oct 30, 2008 |
| Docket number | 09M-0033 |
| Notice date | Jan 27, 2009 |
| Establishment registration | 2243471 |
| FEI number | 2243471 |
At a glance
- 10–99 Supplements
- Aug 11, 2021 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- No Withdrawn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: