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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDIASORIN ETI-CORE-IGMK PLUS ASSAY
Applicant
DIASORIN, INC.
1951 northwestern ave.
stillwater, MN 55082-0285
PMA NumberP990044
Date Received07/02/1999
Decision Date03/30/2001
Docket Number 01M-0455
Notice Date 10/09/2001
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE DIASORIN ETI-CORE-IGMK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-CORE-IGMK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY(EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (IGM ANTI-HBC) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-CORE-IGMK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE PRESENCE OF IGM ANTI-HBC, IN THE PRESENCE OF TOTAL ANTIBODY TO HBC (ANTI-HBC) IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR ACUTE INFECTION. THE ABSENCE OF IGM ANTI-HBC, IN THE PRESENCE OF TOTAL ANTI-HBC, IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR RECOVERY FROM HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ETI-CORE-IGMK PLUS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 S014 S015 S016 S017 S018 S019 S020 
S021 
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