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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 HAVAB-M 7180/ HAVAB-M EIA 9843/IMX HAVAB-M 2263
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantAbbott Laboratories
D-49c, Bldg. Ap6c
100 Abbott Park Rd.
Abbott Park North, IL 60064
PMA NumberP790019
Supplement NumberS014
Date Received10/04/2001
Decision Date09/05/2002
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A MANUFACTURERS WORKING CELL BANK (MWCB) AND LIMITING THE NUMBER OF CELL PASSAGES THAT CAN BE PERFORMED FOR ANTIGEN PRODUCTION USING CELLS FROM THE NEW MWCB.
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