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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 HAVAB 2.0
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 NumberS009
Date Received06/09/2000
Decision Date02/02/2004
Reclassified Date02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ABBOTT AXSYM HAVAB 2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT AXSYM HAVAB 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODY TO HEPATITIS A VIRUS (ANTI-HAV) IN HUMAN SERUM OR PLASMA. A TEST FOR ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION OR IN THE IDENTIFICATION OF HAV-SUSCEPTIBLE INDIVIDUALS FOR VACCINATION.
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