VERSANT HCV Genotype 2.0 Assay (LiPA)
FDA premarket approval P160016/S006 · decided 2020-08-27
Approval details
- PMA number
- P160016
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VERSANT HCV Genotype 2.0 Assay (LiPA)
- Generic name
- Assay, genotyping, hepatitis c virus
- Applicant
- Fujirebio Europe N.V.
- Date received
- 2020-07-31
- Decision date
- 2020-08-27
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OBF
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Gent
- Statement
- Manufacturing process change to replace with new RNA QC samples.
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