APTIMA HCV QUANT DX ASSAY
FDA premarket approval P160023 · decided 2017-02-13
Approval details
- PMA number
- P160023
- Trade name
- APTIMA HCV QUANT DX ASSAY
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Hologic, Inc.
- Date received
- 2016-07-08
- Decision date
- 2017-02-13
- Days to decision
- 220 days
- Decision code
- APRL
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for the Aptima HCV Quant Dx. This device is indicated for: The Aptima HCV Quant Dx Assay is a real-time transcription mediated amplification test (TMA) used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals. Plasma may be prepared in ethylenediaminetetraacetic acid (EDTA), anticoagulant citrate dextrose (ACD) solution, and plasma preparation tubes (PPT). Serum may be prepared in serum tubes and ser
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