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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.
 
Trade NameDIASORIN ETI-AB-AUK PLUS ASSAY
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nameeia for antibody to hepatitis b surface antigen
ApplicantDIASORIN S.P.A.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 
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