PMA supplement
P050028 S019: COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 AND COBAS TAQMAN HBV TEST
FDA PMA supplement · Normal 180 Day Track No User Fee · Roche Molecular Systems, Inc.
Key facts
| Original PMA | P050028 |
|---|---|
| Supplement number | S019 |
| 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 HBV TEST V2.0 AND COBAS TAQMAN HBV TEST |
| Generic name | Hepatitis Viral B DNA Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | MKT |
| Received date | May 31, 2011 |
| Decision date | Dec 29, 2011 |
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: