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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Abbott Laboratories
100 abbott park rd.
ap5n-2, dept. 09vb
abbott park, IL 60064
PMA NumberP080023
Supplement NumberS012
Date Received11/23/2011
Decision Date12/21/2011
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the quality control testing used on an incoming raw material and a finished accessory used in the device.