PMA
BP050069: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
FDA PMA · Human immunodeficiency virus (hiv) viral load monitoring test · Roche Molecular Systems, Inc.
Key facts
| PMA number | BP050069 |
|---|---|
| Trade name | COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L |
| Generic name | Human immunodeficiency virus (hiv) viral load monitoring test |
| Applicant | Roche Molecular Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | QUM |
| Approval date | May 11, 2007 |
| Establishment registration | 3004141078 |
| FEI number | 3004624198 |
At a glance
- 10–99 Supplements
- Jul 8, 2021 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: