DIASORIN ETI-CORE-IGMK PLUS ASSAY

FDA Premarket Approval P990044

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-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.

DeviceDIASORIN ETI-CORE-IGMK PLUS ASSAY
ApplicantDIASORIN, INC.
Date Received1999-07-02
Decision Date2001-03-30
Notice Date2001-10-09
PMAP990044
SupplementS
Docket Number01M-0455
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
P990044Original Filing
S029 2021-11-23 30-day Notice
S028 2020-07-16 30-day Notice
S027 2019-08-28 30-day Notice
S026 2019-06-18 30-day Notice
S025 2018-05-30 30-day Notice
S024 2018-03-30 30-day Notice
S023
S022 2018-02-14 30-day Notice
S021 2017-09-18 30-day Notice
S020 2017-04-25 30-day Notice
S019 2017-03-29 30-day Notice
S018 2016-05-10 30-day Notice
S017 2014-06-05 30-day Notice
S016 2013-12-27 30-day Notice
S015 2013-06-05 30-day Notice
S014 2012-11-09 Special (immediate Track)
S013
S012 2012-02-17 30-day Notice
S011 2011-10-18 30-day Notice
S010 2009-11-13 135 Review Track For 30-day Notice
S009 2009-11-13 Real-time Process
S008 2006-12-29 30-day Notice
S007 2005-06-03 30-day Notice
S006
S005 2004-04-05 30-day Notice
S004 2003-04-14 30-day Notice
S003 2003-04-09 Normal 180 Day Track No User Fee
S002 2002-10-17 30-day Notice
S001 2002-01-07 Normal 180 Day Track

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