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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
ApplicantABBOTT LABORATORIES INC
100 ABBOTT PARK ROAD
AP5N-2, DEPT 09VB
ABBOTT PARK, IL 60064
PMA NumberP050042
Supplement NumberS002
Date Received01/11/2007
Decision Date03/05/2007
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO EXTEND THE EXPIRATION DATING OF REAGENTS, CALIBRATORS, AND CONTROLS TO 14 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT ANTI-HCV AND IS INDICATED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN).
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