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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 Assay
Generic NameHepatitis Viral B DNA Detection
Regulation Number866.3174
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP200013
Supplement NumberS022
Date Received08/08/2024
Decision Date09/05/2024
Reclassified Date10/20/2025
Product Code MKT 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to the request to include sample tube label requirements and edits to the the instrument Operations Manual Addendum.
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