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Ortho-Clinical Diagnostics, Inc.

106 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393)Ortho-Clinical Diagnostics, Inc.2025-10-29
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators (DEN210040)Ortho-Clinical Diagnostics, Inc.2023-05-05
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (DEN210038)Ortho-Clinical Diagnostics, Inc.2023-05-05
VITROS Chemistry Products PHBR Slides (K210858)Ortho-Clinical Diagnostics, Inc.2021-08-13
VITROS XT Chemistry Products ALB-TP Slides (K191316)Ortho-Clinical Diagnostics, Inc.2019-06-07
VITROS XT Chemistry Products TBIL-ALKP Slides (K190807)Ortho-Clinical Diagnostics, Inc.2019-04-26
VITROS XT Chemistry Products GLU-Ca Slides (K190520)Ortho-Clinical Diagnostics, Inc.2019-04-03
VITROS XT Chemistry Products TRIG-CHOL Slides (K190490)Ortho-Clinical Diagnostics, Inc.2019-03-27
VITROS XT Chemistry Products UREA-CREA Slides (K190326)Ortho-Clinical Diagnostics, Inc.2019-03-14
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (K182063)Ortho-Clinical Diagnostics, Inc.2018-10-30
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (K182072)Ortho-Clinical Diagnostics, Inc.2018-10-30
VITROS® Automation Solutions (K160495)Ortho-Clinical Diagnostics, Inc.2016-10-18
VITROS Chemistry Products Calibrator Kit 3 (K161140)Ortho-Clinical Diagnostics, Inc.2016-05-20
VITROS CHEMISTRY PRODUCTS TRIG SLIDES (K130332)Ortho-Clinical Diagnostics, Inc.2013-05-31
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III (K123930)Ortho-Clinical Diagnostics, Inc.2013-05-15
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS (K121608)Ortho-Clinical Diagnostics, Inc.2013-02-15
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES (K120765)Ortho-Clinical Diagnostics, Inc.2012-10-24
VITROS CHEMISTRY PRODUCTS DHDL SLIDES (K120609)Ortho-Clinical Diagnostics, Inc.2012-09-07
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; (K093611)Ortho-Clinical Diagnostics, Inc.2010-04-15
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 (K091861)Ortho-Clinical Diagnostics, Inc.2009-09-03
ORTHO T. CRUZI ELISA TEST SYSTEM (K072732)Ortho-Clinical Diagnostics, Inc.2009-04-15
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 (K083680)Ortho-Clinical Diagnostics, Inc.2009-02-27
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM (K081543)Ortho-Clinical Diagnostics, Inc.2008-10-23
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 (K082099)Ortho-Clinical Diagnostics, Inc.2008-08-21
VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K081411)Ortho-Clinical Diagnostics, Inc.2008-06-30
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 (K073157)Ortho-Clinical Diagnostics, Inc.2007-12-07
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (K072443)Ortho-Clinical Diagnostics, Inc.2007-09-24
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) (K072440)Ortho-Clinical Diagnostics, Inc.2007-09-20
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 (K071801)Ortho-Clinical Diagnostics, Inc.2007-07-20
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 (K071216)Ortho-Clinical Diagnostics, Inc.2007-05-25
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 (K071215)Ortho-Clinical Diagnostics, Inc.2007-05-25
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K063164)Ortho-Clinical Diagnostics, Inc.2006-12-28
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS (K063143)Ortho-Clinical Diagnostics, Inc.2006-12-26
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062285)Ortho-Clinical Diagnostics, Inc.2006-12-22
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III (K062460)Ortho-Clinical Diagnostics, Inc.2006-12-15
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 (K063591)Ortho-Clinical Diagnostics, Inc.2006-12-15
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V (K062637)Ortho-Clinical Diagnostics, Inc.2006-11-22
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V (K062094)Ortho-Clinical Diagnostics, Inc.2006-11-22
VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS (K062077)Ortho-Clinical Diagnostics, Inc.2006-11-22
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062123)Ortho-Clinical Diagnostics, Inc.2006-11-16
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (K063144)Ortho-Clinical Diagnostics, Inc.2006-11-13
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS (K060770)Ortho-Clinical Diagnostics, Inc.2006-09-15
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS (K060678)Ortho-Clinical Diagnostics, Inc.2006-09-14
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS (K061588)Ortho-Clinical Diagnostics, Inc.2006-07-21
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 (K061464)Ortho-Clinical Diagnostics, Inc.2006-06-15
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 (K060632)Ortho-Clinical Diagnostics, Inc.2006-06-06
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III (K060940)Ortho-Clinical Diagnostics, Inc.2006-04-24
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 (K060650)Ortho-Clinical Diagnostics, Inc.2006-04-06
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (K052867)Ortho-Clinical Diagnostics, Inc.2005-12-23
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III (K052819)Ortho-Clinical Diagnostics, Inc.2005-12-23
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043386)Ortho-Clinical Diagnostics, Inc.2005-02-07
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043384)Ortho-Clinical Diagnostics, Inc.2005-02-07
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE (K042479)Ortho-Clinical Diagnostics, Inc.2005-01-06
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II (K042838)Ortho-Clinical Diagnostics, Inc.2004-12-09
VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS (K042476)Ortho-Clinical Diagnostics, Inc.2004-12-01
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III (K042520)Ortho-Clinical Diagnostics, Inc.2004-11-30
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN (K042477)Ortho-Clinical Diagnostics, Inc.2004-11-19
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS (K042521)Ortho-Clinical Diagnostics, Inc.2004-11-18
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II (K042643)Ortho-Clinical Diagnostics, Inc.2004-11-18
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC (K042475)Ortho-Clinical Diagnostics, Inc.2004-11-10
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE (K042006)Ortho-Clinical Diagnostics, Inc.2004-10-28
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS (K041863)Ortho-Clinical Diagnostics, Inc.2004-09-20
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS (K041799)Ortho-Clinical Diagnostics, Inc.2004-08-25
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II (K041720)Ortho-Clinical Diagnostics, Inc.2004-08-25
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (K041322)Ortho-Clinical Diagnostics, Inc.2004-06-17
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS (K033300)Ortho-Clinical Diagnostics, Inc.2003-11-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS (K032993)Ortho-Clinical Diagnostics, Inc.2003-10-31
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS (K031031)Ortho-Clinical Diagnostics, Inc.2003-09-29
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (K032296)Ortho-Clinical Diagnostics, Inc.2003-08-13
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 (K030626)Ortho-Clinical Diagnostics, Inc.2003-03-18
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 (K023875)Ortho-Clinical Diagnostics, Inc.2002-12-10
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K023876)Ortho-Clinical Diagnostics, Inc.2002-12-10
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K012593)Ortho-Clinical Diagnostics, Inc.2001-08-30
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K011250)Ortho-Clinical Diagnostics, Inc.2001-06-13
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K003112)Ortho-Clinical Diagnostics, Inc.2000-11-02
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K001885)Ortho-Clinical Diagnostics, Inc.2000-07-20
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 (K001679)Ortho-Clinical Diagnostics, Inc.2000-06-28
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K001310)Ortho-Clinical Diagnostics, Inc.2000-05-05
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA (K001266)Ortho-Clinical Diagnostics, Inc.2000-05-02
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 (K001133)Ortho-Clinical Diagnostics, Inc.2000-04-24
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS (K000566)Ortho-Clinical Diagnostics, Inc.2000-03-09
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS (K994145)Ortho-Clinical Diagnostics, Inc.1999-12-22
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK (K992366)Ortho-Clinical Diagnostics, Inc.1999-10-08
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS (K992349)Ortho-Clinical Diagnostics, Inc.1999-08-24
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK (K990943)Ortho-Clinical Diagnostics, Inc.1999-06-01
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS (K990016)Ortho-Clinical Diagnostics, Inc.1999-05-19
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK (K983875)Ortho-Clinical Diagnostics, Inc.1999-05-14
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS (K990984)Ortho-Clinical Diagnostics, Inc.1999-04-08
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS (K990783)Ortho-Clinical Diagnostics, Inc.1999-03-25
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK (K984289)Ortho-Clinical Diagnostics, Inc.1999-03-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS (K990531)Ortho-Clinical Diagnostics, Inc.1999-03-12
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 (K984166)Ortho-Clinical Diagnostics, Inc.1999-02-05
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK (K983690)Ortho-Clinical Diagnostics, Inc.1999-02-02
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K990026)Ortho-Clinical Diagnostics, Inc.1999-01-29
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS (K983674)Ortho-Clinical Diagnostics, Inc.1999-01-29
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (K984303)Ortho-Clinical Diagnostics, Inc.1999-01-28
VITROS CHEMISTRY PRODUCTS PHBR SLIDES (K984288)Ortho-Clinical Diagnostics, Inc.1999-01-26
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS (K990061)Ortho-Clinical Diagnostics, Inc.1999-01-25
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS (K984321)Ortho-Clinical Diagnostics, Inc.1999-01-22
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY (K983990)Ortho-Clinical Diagnostics, Inc.1998-12-29
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