PMA
P000012: COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0
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 | P000012 |
|---|---|
| Trade name | COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0 |
| 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 | Jul 3, 2001 |
| Docket number | 02M-0083 |
| Notice date | Feb 27, 2002 |
| Establishment registration | 2243471 |
| FEI number | 2243471 |
At a glance
- 10–99 Supplements
- Aug 4, 2016 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: