PMA supplement
P060030 S025: COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Roche Molecular Systems, Inc.
Key facts
| Original PMA | P060030 |
|---|---|
| Supplement number | S025 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM |
| Generic name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | MZP |
| Received date | Mar 29, 2012 |
| Decision date | Jun 7, 2012 |
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: