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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.
 
DeviceAptima HCV Quant Dx Assay
Generic Nameassay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Applicant
HOLOGIC, INC.
10210 genetic center dr
san diego, CA 92121
PMA NumberP160023
Supplement NumberS001
Date Received08/28/2017
Decision Date02/23/2018
Product Code MZP 
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the Aptima HCV Quant Dx Assay on the Panther System with the attachment of the Panther Fusion Module. The changes being approved include the addition of new hardware and updated software.
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