VERSANT HCV Genotype 2.0 Assay (LiPA)
FDA premarket approval P160016/S001 · decided 2018-02-08
Approval details
- PMA number
- P160016
- Supplement
- S001
- Supplement type
- Real-Time Process
- 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
- 2018-01-02
- Decision date
- 2018-02-08
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- OBF
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Gent
- Statement
- Approval for a modification to the assay procedure to allow the VERSANT kPCR Molecular System Sample Preparation module to automatically set up the PCR plate following the RNA extraction step.
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