ETI-EBK-PLUS

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

FDA Premarket Approval P990043 S015

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

Change in the qc test method using commercially available assays for the determination of antibody isotype in raw materials, and the change to add more stringent acceptance criteria for supplier purchased materials common to all devices.

DeviceETI-EBK-PLUS
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 Received2012-02-17
Decision Date2012-03-09
PMAP990043
SupplementS015
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
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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