ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
FDA premarket approval P120012 · decided 2013-06-20
Approval details
- PMA number
- P120012
- Trade name
- ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
- Generic name
- Assay, genotyping, hepatitis c virus
- Applicant
- Abbott Molecular
- Date received
- 2012-07-12
- Decision date
- 2013-06-20
- Days to decision
- 343 days
- Decision code
- APRL
- Product code
- OBF
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR THE ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, AND URACIL-GLYCOSYLASE(UNG). THIS DEVICE IS INDICATED FOR: ABBOTT REALTIME HCV GENOTYPE IITHE ABBOTT REALTIME HCV GENOTYPE II IS AN IN VITRO REVERSE TRANSCRIPTION-POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR USE WITH THE ABBOTT MSAMPLE PREPARATION SYSTEM REAGENTS AND WITH THE ABBOTT M2000SP AND M2000RT INSTRUMENTS FOR THE QUALITATIVE IDENTIFICATION OFHEPATITIS C VIRUS (HCV) GENOTYPES 1, 1A, 1B, AND 2 -
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| simpli-COLLECT STI Test (K243410) | Abbott Molecular | 2025-01-30 |
| Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (K241580) | Abbott Molecular | 2024-12-06 |