PMA P160016

Device: VERSANT HCV Genotype 2.0 Assay (LiPA)
Applicant: Fujirebio Europe N.V.
PMA number: P160016
Supplement: S006
Product code: OBF
Decision date: 2020-09-23
Generic name: Assay, genotyping, hepatitis c virus
Approval order 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.

Current openFDA PMA Record#

Device: VERSANT HCV Genotype 2.0 Assay (LiPA)
Applicant: Fujirebio Europe N.V.
PMA number: P160016
Supplement: S005
Product code: OBF
Generic name: Assay, genotyping, hepatitis c virus
Decision date: 2020-09-23
Decision code: APPR
Date received: 2020-06-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.