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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
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS, INC.
P.O. BOX 2466
BERKELEY, CA 94702-2466
PMA NumberP160016
Supplement NumberS005
Date Received06/08/2020
Decision Date09/23/2020
Reclassified Date 12/22/2021
Product Code OBF 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
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