VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator

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

FDA Premarket Approval P030026 S032

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

Approval for an additional manufacturing site located at npa de méxico s. A. De c. V. Dba nypro, at sor juana ines de la cruz #20150, parque industrial chilpancingo, 22509 tijuana, baja california, mexico, limited to manufacturing of the ortho-clinical diagnostics vitros 3600 immunodiagnostic system.

DeviceVITROS Immunodiagnostic Products Anti-HBc IgM 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 Received2018-01-09
Decision Date2018-07-02
PMAP030026
SupplementS032
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation 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
P030026Original Filing
S037 2022-09-30 Real-time Process
S036 2019-05-21 30-day Notice
S035 2018-10-16 Normal 180 Day Track No User Fee
S034 2018-02-21 Normal 180 Day Track No User Fee
S033 2018-01-16 30-day Notice
S032 2018-01-09 Normal 180 Day Track No User Fee
S031 2015-10-05 30-day Notice
S030 2015-08-10 30-day Notice
S029 2015-01-16 30-day Notice
S028 2013-09-20 30-day Notice
S027 2012-11-29 30-day Notice
S026 2012-10-17 30-day Notice
S025 2012-01-30 30-day Notice
S024 2011-10-05 Real-time Process
S023 2011-05-19 30-day Notice
S022 2011-05-16 135 Review Track For 30-day Notice
S021 2010-12-08 30-day Notice
S020 2010-10-18 30-day Notice
S019 2009-12-01 Normal 180 Day Track No User Fee
S018 2009-05-22 30-day Notice
S017 2009-03-06 30-day Notice
S016 2009-02-20 Normal 180 Day Track
S015 2008-11-13 Normal 180 Day Track No User Fee
S014 2008-02-27 30-day Notice
S013 2007-03-08 30-day Notice
S012 2007-02-07 Special (immediate Track)
S011 2006-08-21 30-day Notice
S010 2006-05-17 30-day Notice
S009 2005-11-14 30-day Notice
S008 2005-09-30 Special (immediate Track)
S007 2005-06-27 30-day Notice
S006 2005-06-03 30-day Notice
S005 2005-04-07 30-day Notice
S004 2004-12-21 30-day Notice
S003 2004-12-15 30-day Notice
S002 2004-10-26 30-day Notice
S001 2004-05-24 30-day Notice

NIH GUDID Devices

Device IDPMASupp
10758750002795 P030026 028
10758750001194 P030026 028
10758750001187 P030026 028

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