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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/HAVAB-M EIA/IMX HAVAB-M
Classification Namehepatitis a test (antibody and igm antibody)
Generic Namehepatitis a test (antibody and igm antibody)
Regulation Number866.3310
Applicant
Abbott Laboratories
d-49c, building ap6c
100 abbott park road
abbott park north, IL 60064-3500
PMA NumberP790019
Supplement NumberS013
Date Received10/03/2001
Decision Date09/05/2002
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO ADD TESTING OF A SENSITIVITY PANEL FOR QUALIFICATION OF THE HEPATITIS A VIRUS EXTRACT USED IN THE HAVAB ASSAYS TO COAT THE SOLID PHASE OF THE BEAD AND TO TIGHTEN ASSAY ACCEPTANCE SPECIFICATIONS FOR HAV ANTIGEN QUALIFICATION.
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