APTIMA HCV Quant Dx Assay
FDA premarket approval P160023/S012 · decided 2019-04-26
Approval details
- PMA number
- P160023
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2019-03-27
- Decision date
- 2019-04-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Change in plastic resin used for reagent storage containers.
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