ETI-AB-COREK PLUS ASSAY

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

FDA Premarket Approval P990045 S012

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-AB-COREK 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 Received2012-02-17
Decision Date2012-03-09
PMAP990045
SupplementS012
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
P990045Original 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 2005-08-03 30-day Notice
S007
S006 2004-04-05 30-day Notice
S005 2003-10-20 Real-time Process
S004 2003-04-07 Normal 180 Day Track No User Fee
S003 2002-10-17 30-day Notice
S002 2002-01-18 Normal 180 Day Track
S001

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