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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.
 
DeviceETI-EBK PLUS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER, MN 55082-0285
PMA NumberP990043
Supplement NumberS019
Date Received12/27/2013
Decision Date01/10/2014
Withdrawal Date 10/10/2023
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.
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