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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
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 NumberP990042
Date Received07/02/1999
Decision Date03/30/2001
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 01M-0453
Notice Date 10/09/2001
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 S016 S017 S018 S019 
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