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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-AB-AUK PLUS ASSAY
ApplicantDIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER, MN 55082-0285
PMA NumberP990042
Date Received07/02/1999
Decision Date03/30/2001
Withdrawal Date 10/10/2023
Docket Number 01M-0453
Notice Date 10/09/2001
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE DIASORIN ETI-AB-AUK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-AB-AUK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN ERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-AB-AUK PLUS IS INTENDED FOR MANUAL USE ONLY. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS FOR SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION. ANTI-HBS IS ALSO USED TO ASSESS LABORATORY DIAGNOSIS OF PAST EXPOSURE TO HEPATITIS B IN POTENTIAL HEPATITIS B VACCINE RECIPIENTS AND TO DETERMINE THE PRESENCE OS AN IMMUNE RESPONSE IN VACCINE RECIPIENTS. THE ANTI-HBS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HVB DISEASE OR THERAPY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S023 S024 S025 
S026 S027 S028 
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