ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV
FDA premarket approval P100017 · decided 2011-05-17
Approval details
- PMA number
- P100017
- Trade name
- ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2010-05-18
- Decision date
- 2011-05-17
- Days to decision
- 364 days
- Decision code
- APRL
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- THE APPROVAL OF REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT REALTIME HCV CALIBRATOR KIT, AND OPTIONAL UNG URACIL-N-GLYCOSYLASE (UNG) FOR USE IN CONJUNCTION WITH ABBOTT REALTIME HCV. THIS DEVICE IS INDICATED FOR: ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, THE ABBOTT REAL TIME HCV ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION- POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR USE WITH THE ABBOTT MSAMPLE PREPARATION SYSTEM REAGENTS AND WITH THE A
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510(k) clearances by this applicant
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|---|---|---|
| Alinity m HCV (K252102) | Abbott Molecular, Inc. | 2025-09-25 |
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| Alinity m CMV (K243485) | Abbott Molecular, Inc. | 2025-07-01 |
| Alinity m BKV (K241921) | Abbott Molecular, Inc. | 2025-03-24 |
| Alinity m Resp-4-Plex (K241573) | Abbott Molecular, Inc. | 2025-02-14 |
| Alinity m HSV 1 & 2 / VZV (K233349) | Abbott Molecular, Inc. | 2024-05-03 |
| Alinity m STI Assay (K222379) | Abbott Molecular, Inc. | 2023-03-03 |
| Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (K212778) | Abbott Molecular, Inc. | 2022-07-15 |