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COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0
FDA PMAClass II (US FDA PMA)
PMA P050028
Identity
- Trade Name
- COBAS TAQMAN HBV TEST FDA PMA
- Generic Name
- Hepatitis Viral B DNA Detection FDA PMA
Identifiers
- PMA Number
- P050028 FDA PMA
- FDA Product Code
- MKT FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3174 FDA PMA
- Regulation Number
- 866.3174 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0 by Roche Molecular Systems, Inc. (hepatitis viral b dna detection) — Class II — FDA_PMA — listed in FDA PMA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P050028 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P050028 24 fields · synced Jun 18, 2026