PMA supplement
BP050069 S082: COBAS? AmpliPrep/COBAS? TaqMan? HIV-1 Test, v 2.0 and; COBAS? TaqMan? HIV-1 Test v2.0 For Use With The High Pure System
FDA PMA supplement · 30-Day Notice · Roche Molecular Systems, Inc.
Key facts
| Original PMA | BP050069 |
|---|---|
| Supplement number | S082 |
| Supplement type | 30-Day Notice |
| Trade name | COBAS? AmpliPrep/COBAS? TaqMan? HIV-1 Test, v 2.0 and; COBAS? TaqMan? HIV-1 Test v2.0 For Use With The High Pure System |
| Generic name | Human immunodeficiency virus (hiv) viral load monitoring test |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | QUM |
| Received date | Jul 17, 2017 |
| Decision date | Aug 7, 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: