VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)
FDA premarket approval P160016 · decided 2017-03-14
Approval details
- PMA number
- P160016
- Trade name
- VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)
- Generic name
- Assay, genotyping, hepatitis c virus
- Applicant
- Fujirebio Europe N.V.
- Date received
- 2016-06-06
- Decision date
- 2017-03-14
- Days to decision
- 281 days
- Decision code
- APRL
- Product code
- OBF
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Gent
- Statement
- Approval for the VERSANT HCV Genotype 2.0 Assay (LiPA) is a line probe assay, which identifies Hepatitis C virus (HCV) genotypes 1 to 6 and subtypes 1a and 1b in human serum or plasma (K2EDTA, ACD-A CPD, and CPDA) samples. The VERSANT HCV Genotype 2.0 Assay (LiPA) is intended to be used as an aid in the management of patients with chronic HCV infection to guide the selection of antiviral treatment.
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