VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS

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

FDA Premarket Approval P000014 S009

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 a change from the qualitative detection of total anti-hbs in human serum to a quantitative detection of total anti-hbs in human serum. The device, as modified, will be marketed under the trade name vitros immunodiagnostic products anti-hbs quantitative reagent pack and vitros immunodiagnostic products anti-hbs calibrators. The vitros immunodiagnostic products anti-hbs quantitative reagent pack is indicated for: "the quantitative in vitro determination of total antibody to hepatitis b surface antigen (anti-hbs) in human serum using the vitros eci/eciq immunodiagnostic system. Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis, in whom etiology is unknown. " the vitros immunodiagnostic products anti-hbs calibrators is indicated for: "for use in the calibration of the vitros ici/eciq immunodiagnostic system for the quantitative in vitro determination of total antibody to hepatitis b surface antigen (anti-hbs) in human serum using the vitros immunodiagnostic products anti-hbs quantitative reagent pack. "

DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS
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 Received2004-09-15
Decision Date2004-09-27
PMAP000014
SupplementS009
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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