PMA supplement
P050028 S056: COBAS TaqMan HBV Test for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
FDA PMA supplement · 30-Day Notice · Roche Molecular Systems, Inc.
Key facts
| Original PMA | P050028 |
|---|---|
| Supplement number | S056 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | COBAS TaqMan HBV Test for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 |
| Generic name | Hepatitis Viral B DNA Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | MKT |
| Received date | Jul 14, 2017 |
| Decision date | Aug 9, 2017 |
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: