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Ortho-Clinical Diagnostics, Inc.

167 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBsAg (P000044/S040)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S031)Ortho-Clinical Diagnostics, Inc.2018-12-17
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S034)Ortho-Clinical Diagnostics, Inc.2018-12-17
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S016)Ortho-Clinical Diagnostics, Inc.2018-12-17
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S035)Ortho-Clinical Diagnostics, Inc.2018-12-17
VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit (P000044/S039)Ortho-Clinical Diagnostics, Inc.2018-12-17
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S032)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S015)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S032)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit (P000044/S038)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S030)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S013)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S034)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit (P000044/S037)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S033)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S029)Ortho-Clinical Diagnostics, Inc.2018-07-02
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S033)Ortho-Clinical Diagnostics, Inc.2018-02-23
HBeAg Reagent Pack and Calibrator (P090028/S014)Ortho-Clinical Diagnostics, Inc.2018-02-16
Vitros Immunodiagnostic Products HBs Ag Reagent Pack and Calibrator (P000044/S036)Ortho-Clinical Diagnostics, Inc.2017-11-09
VITROS Immunodiagnostic Products HBeAg Reagent Pack / VITROS Immunodiagnostic Products HBeAg Calibrator (P090028/S011)Ortho-Clinical Diagnostics, Inc.2017-10-26
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS (P090028/S010)Ortho-Clinical Diagnostics, Inc.2017-09-12
VITROS Immunodiagnostic Products HBsAg Reagent Pack; VITROS Immunodiagnostic Products HBsAg Calibrator (P000044/S035)Ortho-Clinical Diagnostics, Inc.2017-06-27
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S028)Ortho-Clinical Diagnostics, Inc.2016-11-30
VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR (P000044/S034)Ortho-Clinical Diagnostics, Inc.2016-03-30
VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO (P000014/S029)Ortho-Clinical Diagnostics, Inc.2015-12-16
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR (P000044/S033)Ortho-Clinical Diagnostics, Inc.2015-11-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR (P030026/S031)Ortho-Clinical Diagnostics, Inc.2015-11-03
VITROS HBEAG ASSAY (P090028/S009)Ortho-Clinical Diagnostics, Inc.2015-09-08
VITROS ANTI-HBS ASSAY (P000014/S031)Ortho-Clinical Diagnostics, Inc.2015-09-08
VITROS ANTI-HBC IGM ASSAY (P030026/S030)Ortho-Clinical Diagnostics, Inc.2015-09-08
VITROS HBSAG ASSAY (P000044/S032)Ortho-Clinical Diagnostics, Inc.2015-09-08
VITROS ANTI-HCV ASSAY (P010021/S027)Ortho-Clinical Diagnostics, Inc.2015-09-08
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S008)Ortho-Clinical Diagnostics, Inc.2015-07-23
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S026)Ortho-Clinical Diagnostics, Inc.2015-07-23
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S030)Ortho-Clinical Diagnostics, Inc.2015-07-23
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S031)Ortho-Clinical Diagnostics, Inc.2015-07-23
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & VITRO IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR (P010021/S025)Ortho-Clinical Diagnostics, Inc.2015-03-11
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S029)Ortho-Clinical Diagnostics, Inc.2015-02-12
VITROS IMMUNODIAGNOSTIC ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATORS (P000014/S028)Ortho-Clinical Diagnostics, Inc.2014-12-11
ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS (P000014/S027)Ortho-Clinical Diagnostics, Inc.2014-03-10
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S007)Ortho-Clinical Diagnostics, Inc.2013-10-17
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S028)Ortho-Clinical Diagnostics, Inc.2013-10-17
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK (P010021/S024)Ortho-Clinical Diagnostics, Inc.2013-03-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM (P030026/S027)Ortho-Clinical Diagnostics, Inc.2012-12-21
VITROS IMMUNODIAGNOSTIC PRODUCTS ABEAG (P090028/S006)Ortho-Clinical Diagnostics, Inc.2012-12-21
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK CALIBRATOR (P090028/S005)Ortho-Clinical Diagnostics, Inc.2012-11-26
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S030)Ortho-Clinical Diagnostics, Inc.2012-11-13
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S004)Ortho-Clinical Diagnostics, Inc.2012-11-13
VITROS ANTI-HBS (P000014/S026)Ortho-Clinical Diagnostics, Inc.2012-11-13
VITROS ANTI-HBC IGM (P030026/S026)Ortho-Clinical Diagnostics, Inc.2012-11-13
VITROS ANTI-HCV (P010021/S023)Ortho-Clinical Diagnostics, Inc.2012-11-13
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S003)Ortho-Clinical Diagnostics, Inc.2012-10-17
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR (P090028/S002)Ortho-Clinical Diagnostics, Inc.2012-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR (P000014/S025)Ortho-Clinical Diagnostics, Inc.2012-03-13
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S029)Ortho-Clinical Diagnostics, Inc.2012-02-23
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK CALIBRATOR (P030026/S025)Ortho-Clinical Diagnostics, Inc.2012-02-23
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S022)Ortho-Clinical Diagnostics, Inc.2012-02-23
VITROS INMMUNODIAGNOSTIC PRODUCTS ANTI-HCV ASSAY (P010021/S021)Ortho-Clinical Diagnostics, Inc.2011-11-10
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM ASSAY (P030026/S024)Ortho-Clinical Diagnostics, Inc.2011-11-10
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS ASSAY (P000014/S024)Ortho-Clinical Diagnostics, Inc.2011-11-10
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG ASSAY AND HBSAG CONFIRMATORY KIT (P000044/S028)Ortho-Clinical Diagnostics, Inc.2011-11-10
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK & CALIBRATOR (P090028/S001)Ortho-Clinical Diagnostics, Inc.2011-10-21
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S022)Ortho-Clinical Diagnostics, Inc.2011-09-27
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S027)Ortho-Clinical Diagnostics, Inc.2011-09-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S020)Ortho-Clinical Diagnostics, Inc.2011-09-15
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S019)Ortho-Clinical Diagnostics, Inc.2011-08-02
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S023)Ortho-Clinical Diagnostics, Inc.2011-06-14
VITROS IMMUNODIAGNOSTICS PRODUCTS HBSAG REAGENT PACK & CALIBRATOR (P000044/S026)Ortho-Clinical Diagnostics, Inc.2011-05-11
VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS (P090028)Ortho-Clinical Diagnostics, Inc.2011-05-11
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S021)Ortho-Clinical Diagnostics, Inc.2011-04-22
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S023)Ortho-Clinical Diagnostics, Inc.2011-03-10
VITROS IMMUNDIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S020)Ortho-Clinical Diagnostics, Inc.2010-11-16
VITROS IMMUNODIAGNOSTICS HBSAG REAGENT PACK & CALIBRATOR (P000044/S025)Ortho-Clinical Diagnostics, Inc.2010-11-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S022)Ortho-Clinical Diagnostics, Inc.2010-11-16
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR; HBSAG CONFIRMATORY KIT (P000044/S024)Ortho-Clinical Diagnostics, Inc.2010-08-30
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S021)Ortho-Clinical Diagnostics, Inc.2010-08-19
HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT (P000044/S023)Ortho-Clinical Diagnostics, Inc.2010-07-16
ANTI-HBC REAGENT PACK AND CALIBRATOR (P030026/S019)Ortho-Clinical Diagnostics, Inc.2010-07-16
ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S017)Ortho-Clinical Diagnostics, Inc.2010-07-16
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR (P000014/S020)Ortho-Clinical Diagnostics, Inc.2010-07-16
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S018)Ortho-Clinical Diagnostics, Inc.2010-05-20
VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S019)Ortho-Clinical Diagnostics, Inc.2010-01-11
VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI (P000044/S020)Ortho-Clinical Diagnostics, Inc.2009-10-23
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT (P000044/S022)Ortho-Clinical Diagnostics, Inc.2009-10-20
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S016)Ortho-Clinical Diagnostics, Inc.2009-07-15
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S016)Ortho-Clinical Diagnostics, Inc.2009-07-15
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S018)Ortho-Clinical Diagnostics, Inc.2009-06-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK & CALIBRATORS (P000014/S018)Ortho-Clinical Diagnostics, Inc.2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS (P000044/S021)Ortho-Clinical Diagnostics, Inc.2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS (P010021/S015)Ortho-Clinical Diagnostics, Inc.2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S017)Ortho-Clinical Diagnostics, Inc.2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR (P000044/S019)Ortho-Clinical Diagnostics, Inc.2009-01-14
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