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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.
 
DeviceABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Ap5n-2, Dept. 09vb
Abbott Park, IL 60064
PMA NumberP970027
Supplement NumberS007
Date Received11/13/2008
Decision Date07/08/2009
Withdrawal Date11/08/2013
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE ANTIMICROBIAL FORMULATION TO THE AXSYM ANTI-HCV REAGENT SDB2 (SPECIMEN DILUENT). IN ADDITION, DUE TO THE REFORMULATION OF THE SDB2, THE INSTRUCTION TO USE STERILE WATER FOR TUBING DECONTAMINATION IS NO LONGER A REQUIRED PROCEDURE AND CAN BE REMOVED FROM THE PACKAGE INSERT LABELING.
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