APTIMA HCV RNA QUALITATIVE ASSAY
FDA premarket approval P020011/S009 · decided 2016-09-19
Approval details
- PMA number
- P020011
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- APTIMA HCV RNA QUALITATIVE ASSAY
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Gen-Probe
- Date received
- 2015-09-04
- Decision date
- 2016-09-19
- Days to decision
- 381 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval of a new supplier for a critical raw material.
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