VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

FDA Premarket Approval P000014 S036

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

Amendment of the assay specific release for sale limits and customer calibration limits used with immunodiagnostic products, vitros anti-hbs reagent pack and calibrators.

DeviceVITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantOrtho-Clinical Diagnostics, Inc.
Date Received2020-09-22
Decision Date2020-10-22
PMAP000014
SupplementS036
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. rochester, NY 14626-5101

Supplemental Filings

Supplement NumberDateSupplement Type
P000014Original Filing
S036 2020-09-22 30-day Notice
S035 2019-05-21 30-day Notice
S034 2018-10-16 Normal 180 Day Track No User Fee
S033 2018-02-21 Normal 180 Day Track No User Fee
S032 2018-01-09 Normal 180 Day Track No User Fee
S031 2015-08-10 30-day Notice
S030 2015-06-25 30-day Notice
S029 2015-06-24 Normal 180 Day Track
S028 2014-11-14 30-day Notice
S027 2014-02-14 30-day Notice
S026 2012-10-17 30-day Notice
S025 2012-02-15 30-day Notice
S024 2011-10-05 Real-time Process
S023 2011-02-14 30-day Notice
S022 2010-10-18 30-day Notice
S021 2010-07-27 30-day Notice
S020 2009-12-01 Normal 180 Day Track No User Fee
S019 2009-09-04 Normal 180 Day Track
S018 2009-03-06 30-day Notice
S017 2008-11-13 Normal 180 Day Track No User Fee
S016 2008-01-23 30-day Notice
S015 2007-05-11 30-day Notice
S014 2006-05-12 30-day Notice
S013 2005-11-21 30-day Notice
S012 2005-05-09 30-day Notice
S011 2005-03-01 30-day Notice
S010 2004-10-26 30-day Notice
S009 2004-09-15 Real-time Process
S008 2004-07-07 30-day Notice
S007 2004-05-05 30-day Notice
S006 2003-06-16 30-day Notice
S005 2003-01-30 30-day Notice
S004 2001-03-26 Normal 180 Day Track
S003 2001-03-22 30-day Notice
S002 2001-03-12 135 Review Track For 30-day Notice
S001 2001-03-05 30-day Notice

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