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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.
 
DeviceEBK RIA ASSAY/ETI-EBK
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantDiasorin
1951 Northwestern Ave.
P.O. Box 285
Stillwater, MN 55082
PMA NumberP870048
Supplement NumberS008
Date Received10/05/2000
Decision Date02/02/2001
Withdrawal Date09/18/2007
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE NEGATIVE AND POSITIVE CONTROLS AND THE NEUTRALIZING SOLUTIONS FROM DEFIBRINATED PLASMA TO SERUM AND A CHANGE IN THE PURIFICATION PROCESS AND SHELF LIFE OF SOME COMPONENTS OF THE EBK DEVICE AND THE ETI-EBK DEVICE.
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