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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
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantAbbott Laboratories, Inc.
100 Abbott Park Rd.
Ap5n-2, Dept. 09vb
Abbott Park, IL 60064
PMA NumberP050042
Supplement NumberS017
Date Received07/05/2012
Decision Date07/31/2012
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO USE NEW CONTAINERS FOR MANUFACTURING OF MICROPARTICLE BASEDCOMPONENTS AND IMPLEMENTING A NEW TEST TO VERIFY THE EFFECTIVENESS OF THE PREVENTIVE ACTION.
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