PMA
P150014: COBAS HBV TEST
FDA PMA · Hepatitis Viral B DNA Detection · Roche Molecular Systems, Inc.
Key facts
| PMA number | P150014 |
|---|---|
| Trade name | COBAS HBV TEST |
| Generic name | Hepatitis Viral B DNA Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | MKT |
| Approval date | Oct 14, 2015 |
| Docket number | 15M-4069 |
| Notice date | Nov 5, 2015 |
| Establishment registration | 2243471 |
| FEI number | 2243471 |
At a glance
- 10–99 Supplements
- Oct 17, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: