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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.
 
DeviceDIASORIN ETI-MAK-2 PLUS ASSAY
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, INC.
1951 northwestern ave.
stillwater, MN 55082-0285
PMA NumberP990038
Supplement NumberS005
Date Received07/16/2003
Decision Date08/20/2003
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A REVISION IN THE ASSAY PACKAGE INSERT THAT INCORPORATES A CHANGE IN THE INTERPRETATION ALGORITHM FOR REPEAT TESTING RESULTS THAT MAKE IT THE SAME AS THE INTERPRETATION FOR INITIAL TESTING. "THE USER SHOULD APPLY THE SAME INTERPRETATION OF RESULTS (I.E. REACTIVE SAMPLES SHOULD HAVE AN ABSORBANCE VALUE GREATER THAN 90% OF THE CUTOFF) WHEN INITIAL TESTING FOR SOME SAMPLES AND REPEAT TESTING FOR OTHER SAMPLES ARE PERFORMED ON THE SAME PLATE."
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