Aptima HCV Quant Dx Assay
FDA premarket approval P160023/S001 · decided 2018-02-23
Approval details
- PMA number
- P160023
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2017-08-28
- Decision date
- 2018-02-23
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for the use of the Aptima HCV Quant Dx Assay on the Panther System with the attachment of the Panther Fusion Module. The changes being approved include the addition of new hardware and updated software.
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510(k) clearances by this applicant
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