PMA P160016S001

Device: VERSANT HCV Genotype 2.0 Assay (LiPA)
Applicant: Fujirebio Europe N.V.
PMA number: P160016
Supplement: S001
Product code: OBF
Decision date: 2018-02-08
Classification: Assay, Genotyping, Hepatitis C Virus
Generic name: Assay, genotyping, hepatitis c virus
Approval order 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.

Current openFDA PMA Record#

Device: VERSANT HCV Genotype 2.0 Assay (LiPA)
Applicant: Fujirebio Europe N.V.
PMA number: P160016
Supplement: S001
Product code: OBF
Generic name: Assay, genotyping, hepatitis c virus
Decision date: 2018-02-08
Decision code: APPR
Date received: 2018-01-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.