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PMA P160016S005

Device
VERSANT HCV Genotype 2.0 Assay (LiPA)
Applicant
Fujirebio Europe N.V.
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.