Identity
- Trade Name
- ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) FDA PMA
- Generic Name
- Assay, genotyping, hepatitis c virus FDA PMA
Identifiers
- PMA Number
- P120012 FDA PMA
- FDA Product Code
- OBF FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3170 FDA PMA
- Regulation Number
- 866.3170 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
Abbott Realtime Hcv Genotype Ii by Abbott Molecular (assay, genotyping, hepatitis c virus) — 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 | P120012 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA PMA P120012 24 fields · synced Jun 18, 2026