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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.
 
DeviceARCHITECT Anti-HCV, Alinity i Anti-HCV
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantABBOTT LABORATORIES INC
100 ABBOTT PARK ROAD
AP5N-2, DEPT 09VB
ABBOTT PARK, IL 60064
PMA NumberP050042
Supplement NumberS044
Date Received07/31/2020
Decision Date08/28/2020
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modifications to the sourcing and testing of materials used in the manufacture of an internal reference panel, which is used for quality control evaluation during in-process reagent manufacturing.
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