VERSANT HCV Genotype 2.0 Assay (LiPA)
FDA premarket approval P160016/S005 · decided 2020-09-23
Approval details
- PMA number
- P160016
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VERSANT HCV Genotype 2.0 Assay (LiPA)
- Generic name
- Assay, genotyping, hepatitis c virus
- Applicant
- Fujirebio Europe N.V.
- Date received
- 2020-06-08
- Decision date
- 2020-09-23
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- OBF
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Gent
- Statement
- Approval to replace the Triton X-705 detergent, a component of the 5X Rinse Solution and Conjugate Diluent used in the VERSANT HCV Genotyping 2.0 Assay, with the detergent Tergitol 15-S-40.
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