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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 HBV
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP200013
Supplement NumberS026
Date Received07/02/2025
Decision Date09/24/2025
Reclassified Date10/20/2025
Product Code MKT 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for creating an Alinity m Systems Liner (“Liner”) as a containment device placed underneath the Alinity m System to catch fluids that may leak from the reagent storage and dispense portions of the instrument.
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