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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic Nameassay, genotyping, hepatitis c virus
Regulation Number866.3170
p.o. box 2466
berkeley, CA 94702-2466
PMA NumberP160016
Date Received06/06/2016
Decision Date03/14/2017
Reclassified Date 12/22/2021
Product Code OBF 
Docket Number 17M-1713
Notice Date 04/21/2017
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S003 S004 S005 S006