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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.
 
DeviceAAV5 DetectCDx®
Generic NameAssays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
ApplicantARUP Laboratories
500 Chipeta Way
Salt Lake City, UT 84108
PMA NumberP190033
Supplement NumberS001
Date Received09/05/2024
Decision Date10/04/2024
Withdrawal Date07/15/2026
Product Code QWQ 
Advisory Committee Hematology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
To change the scale of size exclusion chromatography, and accept SULFO-TAG AAV5 Capsid below previously-defined method acceptance criteria.
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