VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator

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

FDA Premarket Approval P030024 S028

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 eci/eciq immunodiagnostic system.

DeviceVITROS Immunodiagnostic Products Anti-HBc 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
Date Received2018-10-16
Decision Date2018-12-17
PMAP030024
SupplementS028
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 100 Indigo Creek Dr. rochester, NY 14626-5101

Supplemental Filings

Supplement NumberDateSupplement Type
P030024Original Filing
S029 2019-05-21 30-day Notice
S028 2018-10-16 Normal 180 Day Track No User Fee
S027 2018-09-17 30-day Notice
S026 2018-02-21 Normal 180 Day Track No User Fee
S025 2018-01-09 Normal 180 Day Track No User Fee
S024 2017-08-07 30-day Notice
S023 2015-08-10 30-day Notice
S022 2015-06-25 30-day Notice
S021 2013-08-12 30-day Notice
S020 2012-10-17 30-day Notice
S019 2012-05-04 30-day Notice
S018 2012-01-30 30-day Notice
S017 2011-10-05 Real-time Process
S016 2011-05-16 135 Review Track For 30-day Notice
S015 2011-04-15 30-day Notice
S014 2010-12-06 135 Review Track For 30-day Notice
S013 2010-10-18 30-day Notice
S012 2009-12-01 Normal 180 Day Track No User Fee
S011 2009-03-06 30-day Notice
S010 2009-02-12 Normal 180 Day Track
S009 2008-11-13 Normal 180 Day Track No User Fee
S008 2008-01-23 30-day Notice
S007 2007-12-10 Real-time Process
S006 2007-05-11 30-day Notice
S005 2006-05-15 30-day Notice
S004 2005-11-14 30-day Notice
S003 2005-04-08 Special (immediate Track)
S002 2004-10-26 30-day Notice
S001 2004-03-17 30-day Notice

NIH GUDID Devices

Device IDPMASupp
10758750002771 P030024 021
10758750001224 P030024 021
10758750001217 P030024 021

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