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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 CMV Assay
Generic NameCytomegalovirus (cmv) dna quantitative assay
Regulation Number866.3180
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP210022
Supplement NumberS013
Date Received08/08/2024
Decision Date09/05/2024
Reclassified Date10/23/2024
Product Code PAB 
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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