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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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 
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