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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
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)
Applicant
DIASORIN
1951 northwestern avenue
po box 285
stillwater, MN 55082-0285
PMA NumberP870048
Supplement NumberS008
Date Received10/05/2000
Decision Date02/02/2001
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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