VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR

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

FDA Premarket Approval P000044 S031

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 for the introduction of a new piece of manufacturing equipment to pack coated wells into reagent packs.

DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR
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)
ApplicantOrtho-Clinical Diagnostics, Inc.
Date Received2015-06-25
Decision Date2015-07-23
PMAP000044
SupplementS031
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
P000044Original Filing
S040 2019-05-21 30-day Notice
S039 2018-10-16 Normal 180 Day Track No User Fee
S038 2018-02-21 Normal 180 Day Track No User Fee
S037 2018-01-09 Normal 180 Day Track No User Fee
S036 2017-10-17 30-day Notice
S035 2017-05-30 30-day Notice
S034 2016-03-02 30-day Notice
S033 2015-10-29 30-day Notice
S032 2015-08-10 30-day Notice
S031 2015-06-25 30-day Notice
S030 2012-10-17 30-day Notice
S029 2012-01-30 30-day Notice
S028 2011-10-05 Real-time Process
S027 2011-08-19 30-day Notice
S026 2011-04-28 30-day Notice
S025 2010-10-18 30-day Notice
S024 2010-08-06 30-day Notice
S023 2009-12-01 Normal 180 Day Track No User Fee
S022 2009-09-30 30-day Notice
S021 2009-03-06 30-day Notice
S020 2009-02-02 Normal 180 Day Track
S019 2008-11-13 Normal 180 Day Track No User Fee
S018 2008-05-15 30-day Notice
S017 2008-01-23 30-day Notice
S016 2007-03-21 30-day Notice
S015 2007-03-12 30-day Notice
S014 2006-08-08 30-day Notice
S013 2006-05-25 Real-time Process
S012 2006-05-12 30-day Notice
S011 2006-03-15 30-day Notice
S010 2005-11-18 30-day Notice
S009 2005-10-26 30-day Notice
S008 2005-09-02 30-day Notice
S007 2005-07-13 30-day Notice
S006 2005-04-08 Special (immediate Track)
S005 2004-11-15 30-day Notice
S004 2004-10-26 30-day Notice
S003 2003-03-06 30-day Notice
S002 2001-05-29 30-day Notice
S001 2001-05-04 30-day Notice

NIH GUDID Devices

Device IDPMASupp
10758750002764 P000044 030
10758750001088 P000044 030
10758750001071 P000044 030
10758750001064 P000044 030

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