Abbott RealTime HCV Genotype II Assay
FDA premarket approval P120012/S017 · decided 2018-06-21
Approval details
- PMA number
- P120012
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Abbott RealTime HCV Genotype II Assay
- Generic name
- Assay, genotyping, hepatitis c virus
- Applicant
- Abbott Molecular
- Date received
- 2018-05-25
- Decision date
- 2018-06-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OBF
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Modify the manufacturing and QC testing for a kit component and tighten an incoming reagent specification.
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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 |