ETI-AB-EBK PLUS ASSAY

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

FDA Premarket Approval P990041 S018

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of hbsag positive samples.

DeviceETI-AB-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 Received2013-12-27
Decision Date2014-01-10
PMAP990041
SupplementS018
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DIASORIN, INC. 1951 Northwestern Ave. stillwater, MN 55082-0285

Supplemental Filings

Supplement NumberDateSupplement Type
P990041Original Filing
S031 2021-11-23 30-day Notice
S030 2020-07-16 30-day Notice
S029 2019-08-28 30-day Notice
S028 2019-06-18 30-day Notice
S027 2018-05-30 30-day Notice
S026 2018-03-30 30-day Notice
S025
S024 2018-02-14 30-day Notice
S023 2017-09-18 30-day Notice
S022 2017-04-25 30-day Notice
S021 2017-03-29 30-day Notice
S020 2016-05-10 30-day Notice
S019 2014-06-05 30-day Notice
S018 2013-12-27 30-day Notice
S017 2013-06-05 30-day Notice
S016 2012-11-09 Special (immediate Track)
S015
S014 2012-02-17 30-day Notice
S013 2011-10-18 30-day Notice
S012 2009-11-13 135 Review Track For 30-day Notice
S011 2009-11-13 Real-time Process
S010 2009-01-29 30-day Notice
S009 2006-12-29 30-day Notice
S008 2005-06-03 30-day Notice
S007
S006 2004-04-05 30-day Notice
S005 2004-03-11 30-day Notice
S004 2004-01-30 Special (immediate Track)
S003 2003-04-18 Normal 180 Day Track No User Fee
S002 2002-10-17 30-day Notice
S001 2002-01-22 Normal 180 Day Track

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