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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.
 
DeviceIMX(R) HAVAB
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantAbbott Laboratories
100 Abbott Park Rd.
D-049c/Ap6c-2
Abbott Park, IL 60064
PMA NumberP780012
Supplement NumberS008
Date Received02/06/1998
Decision Date05/12/1998
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Abbott IMx(R) HAVAB(R). This device is indicated for the qualitative determiantion of total antibody to heaptitis A antigen in human serum or plasma.
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