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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceVERSANT HCV Genotype 2.0 Assay (LiPA)
Generic Nameassay, genotyping, hepatitis c virus
Regulation Number866.3170
p.o. box 2466
berkeley, CA 94702-2466
PMA NumberP160016
Supplement NumberS001
Date Received01/02/2018
Decision Date02/08/2018
Reclassified Date 12/22/2021
Product Code OBF 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
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.