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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-M 2.0
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 NumberS011
Date Received06/09/2000
Decision Date02/02/2004
Reclassified Date 02/09/2006
Product Code LOL 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ABBOTT AXSYM HAVAB-M 2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AXSYM HAVAB-M 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION IF IGM ANTIBODY TO HEPATITIS A VIRUS (IGM ANTI-HAV) IN HUMAN SERUM OR PLASMA. A TEST FOR IGM ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS A VIRAL INFECTION.
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