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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-MAK-2 PLUS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantDIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER, MN 55082-0285
PMA NumberP990038
Supplement NumberS011
Date Received03/24/2006
Decision Date04/19/2006
Withdrawal Date 10/10/2023
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MANUFACTURING CHANGES IN THE WAY THE POSITIVE CONTROL IS MADE.
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