DIASORIN ETI-EBK PLUS ASSAY

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Approval P990043

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.

Pre-market Approval Supplement Details

Approval for the diasorin eti-ebk plus assay. The device is indicated for the qualitative detection of hepatitis be antigen (hbeag) in human serum or plasma (edta, citrate or heparin). The eti-ebk plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of hbeag is indicative of active hbv replication, usually correlating with viremia. A reactive test is presumptive laboratory evidence for infection with hepatitis b virus (hbv). Further hbv serological marker testing is required to define the specific disease state. The hbeag assay's performance has not been established for the monitoring of hbv disease or therapy.

DeviceDIASORIN ETI-EBK 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)
ApplicantDIASORIN, INC.
Date Received1999-07-02
Decision Date2001-02-08
Notice Date2001-10-09
PMAP990043
SupplementS
Product CodeLOM
Docket Number01M-0454
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address DIASORIN, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P990043Original Filing
S032 2021-11-23 30-day Notice
S031 2020-07-16 30-day Notice
S030 2019-08-28 30-day Notice
S029 2019-06-18 30-day Notice
S028 2018-05-30 30-day Notice
S027 2018-03-30 30-day Notice
S026
S025 2018-02-14 30-day Notice
S024 2017-09-18 30-day Notice
S023 2017-04-25 30-day Notice
S022 2017-03-29 30-day Notice
S021 2016-05-10 30-day Notice
S020 2014-06-05 30-day Notice
S019 2013-12-27 30-day Notice
S018 2013-06-05 30-day Notice
S017 2012-11-09 Special (immediate Track)
S016
S015 2012-02-17 30-day Notice
S014 2011-08-18 30-day Notice
S013 2009-11-13 135 Review Track For 30-day Notice
S012 2009-11-13 Real-time Process
S011 2009-01-29 30-day Notice
S010 2006-12-29 30-day Notice
S009 2005-06-03 30-day Notice
S008
S007 2004-04-05 30-day Notice
S006 2004-03-11 30-day Notice
S005 2004-01-30 Special (immediate Track)
S004 2003-04-10 Normal 180 Day Track No User Fee
S003 2002-10-17 30-day Notice
S002 2002-01-22 Normal 180 Day Track
S001

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