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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.
 
DeviceAlinity m HCV
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
ApplicantAbbott Molecular, Inc.
1300 E. Touhy Avenue
Des Plaines, IL 60018
PMA NumberP190025
Supplement NumberS006
Date Received04/15/2021
Decision Date06/01/2021
Reclassified Date 12/22/2021
Product Codes MZP OOI 
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 tp release the software version 1.6.2 in the United States, incorporating into the Alinity m System Software version 1.6.0, version 1.6.1 and 1.6.2, which are currently released outside, the US.
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