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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.
 
DeviceHAVAB-M EIA
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantAbbott Laboratories
D-49C, BUILDING AP6C
100 ABBOTT PARK ROAD
ABBOTT PARK NORTH, IL 60064-3500
PMA NumberP790019
Supplement NumberS016
Date Received10/07/2002
Decision Date11/06/2002
Reclassified Date 02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES TO 1) REPLACE LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM LITTON BIONETICS WITH NON-LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM JACKSON IMMUNO RESEARCH. 2) REPLACE RHEOPHORESIS TESTING FOR GOAT ANTI-HUMAN IGM (ANTIBODY) IDENTITY/SPECIFICITY WITH IMMUNOELECTRO-PHORESIS (IEP) TESTING. 3) REPLACE HAVAB-M RIA (RADIOIMMUNOASSAY) ANTIBODY BEAD COAT EFFICACY TESTING WITH SMALL-SCALE ANTIBODY DILUTION FACTOR DETERMINATION AND CONFIRMATION TESTING USING HAVAB-M EIA (ENZYME IMMUNOASSAY) TO ESTABLISH THE OPTIMAL DILUTION FACTOR OF THE GOAT ANTI-HUMAN IGM ANTIBODY TO BE USED FOR FULL-SCALE PRODUCTION BEAD COATING.
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