FDA.reportPublic FDA data

Ortho Clinical Diagnostics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30026423963002642396Ortho Clinical Diagnostics1N2026-01-011 International Business Park, The Synergy #01-11/12 Singapore South West SG 609917
30124667843012466784Ortho Clinical Diagnostics c/o Kuehne + Nagel1Y2020-04-256005 Freeport Avenue Memphis TN US 38141

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3122881385088354P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLSSEI2011-07-20
3122881433667431P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLSLOM2011-05-11
3122881909123349P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
3122881039148954P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
3122881876315254P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
3122881385779327P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNRLOM2001-04-27
3122882070006446P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
3122881545196239K983690VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKMOI1999-02-02
3122881721546618K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
3122881757233346K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
3122881194774061K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
3122881796900905K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
3122881522269507K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)CHP1997-03-18
3122881836532856K965142VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)CEC1997-03-18
3122881483979437K964960VITROS CHEMISTRY PRODUCTS UPRO SLIDESJGP1997-02-18
3122881417738613K964721VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)KLI1996-12-18
3122881183794043K964720VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)CGJ1997-02-04
3122881409395610K962919VITROS IMMUNODIAGNOSTIC SYSTEMKHO1996-10-18
3122881939127048K954933EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHENLDP1995-12-18
3122881408645809K953197EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)DCK1995-07-31
3122881109563874K942610KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)LFM1994-10-20
3122881924001264K934273KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)DMT1994-03-21
3122881077310998K924488KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)JIH1993-01-26
3122881789082088K922072KODAK EKTACHEM 250 ANALYERJJE1992-07-10
3122881678798591K910143KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)JIY1991-02-04
3122881949666447K903189KODATROL LIQUID CONTROL LEVELS I & IIDIF1990-08-22
3122881638493628K902356KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)DKJ1990-07-16
3122881214230933K861367KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)KLS1986-05-29
3122881524183834K840606EKTACHEM CLINICAL CHEM. SLIDESCIG1984-04-04
3122882068406495K820723KODAK EKTACHEM CLINICAL CHEM. NH3JID1982-04-01
3122881281180688K812027KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)CIW1981-08-03
3122881371050299K801649KODAK EKTACHEM CLINICAL CHEMISTRY SLIDESKNK1980-08-20
3122881861676557K791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONKSG1979-10-11
3122881428615879K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA2024-05-08
3122881069340945K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG2023-08-09
3122881791884017K231517VITROS Immunodiagnostic Products CEA Reagent PackDHX2023-08-23
3122881282088727K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK2022-12-12
3122881785280034K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW2023-09-05
3122881294492458K212648VITROS Immunodiagnostic Products CK-MB Reagent PackJHX2022-01-28
3122881695967673K210858VITROS Chemistry Products PHBR SlidesDLZ2021-08-13
3122881133252456K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC2021-10-04
3122881509633778K200236VITROS BRAHMS PCT Reagent Pack and CalibratorsPMT2020-02-25
3122881226337325K191316VITROS XT Chemistry Products ALB-TP SlidesCIX2019-06-07
3122881740227709K190807VITROS XT Chemistry Products TBIL-ALKP SlidesCIG2019-04-26
3122881832500402K190520VITROS XT Chemistry Products GLU-Ca SlidesCGA2019-04-03
3122881946970502K190490VITROS XT Chemistry Products TRIG-CHOL SlidesCHH2019-03-27
3122881197415690K190326VITROS XT Chemistry Products UREA-CREA SlidesCDN2019-03-14
3122881815129592K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemJFY2018-10-30
3122881317000412K160712VITROS Chemistry Products hsCRP ReagentDCK2017-07-14
3122881509093750K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and IIPDJ2015-06-04
3122881801182073K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESCDT2013-05-31
3122881054257610K123930VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND IIILPS2013-05-15
3122881279267715K121608VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORSMRG2013-02-15
3122881352147947K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESLBS2012-09-07
3122881650595488K101921VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VITCEW2010-10-22
3122881799775839K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMJLW2008-12-22
3122882011202475K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMJLW2008-10-23
3122881846625306K081411VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2JGS2008-06-30
3122881833120988K073157VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2CEM2007-12-07
3122881036154314K072440VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)CJY2007-09-20
3122881996030432K063720VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERSDHA2007-04-09
3122881329574504K063164VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IVLDJ2006-12-28
3122881452233425K062838VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303MMI2006-12-19
3122881381141527K062637VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & VDJR2006-11-22
3122881836079730K062460VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND IIIDJG2006-12-15
3122881624343505K062285VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IVJXM2006-12-22
3122881521610139K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSDIS2007-01-05
3122881547196623K062123VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IVDIO2006-11-16
3122882071253668K062094VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & VLCM2006-11-22
3122881377598937K062077VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSDKZ2006-11-22
3122881379663994K061464VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668JMO2006-06-15
3122881591700812K060770VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLSLOL2006-09-15
3122881980739229K060678VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLSLOL2006-09-14
3122881457881243K060632VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158NBC2006-06-06
3122881772348712K060480VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLSCGR2006-07-03
3122881118348934K052889VITROS CA 19-9NIG2005-12-20
3122881543544029K052867VITROS CHEMISTRY PRODUCTS DTIBC REAGENTJMO2005-12-23
3122881443702967K052819VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND IIIDEM2005-12-23
3122881790813102K052645VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;GTQ2005-12-14
3122881748929405K043386VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND IIILEH2005-02-07
3122881492619590K043384VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND IIILDO2005-02-07
3122881990224715K042838VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & IIJIT2004-12-09
3122881425959969K042643VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND IIDCF2004-11-18
3122882007765821K042521VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERSJIT2004-11-18
3122881362672868K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIKLS2004-11-30
3122881876970905K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIICZW2004-10-19
3122881313910226K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHELCD2005-01-06
3122881874194284K042477VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEINDDG2004-11-19
3122881420712059K042476VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOSLEG2004-12-01
3122881930557530K042475VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCCFN2004-11-10
3122881079970070K042303VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLSJJX2004-09-27
3122881981076953K042006VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACELBS2004-10-28
3122881685499316K041863VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FSDHR2004-09-20
3122881138517118K041799VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FSNQD2004-08-25
3122881266150508K041720VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND IIMRR2004-08-25
3122881312314339K041322VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERSDHX2004-06-17
3122881722759354K033300VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERSDDR2003-11-05
3122881523796309K033127VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLSJJX2003-10-31
3122881379237638K032993VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLSJJX2003-10-31
3122881481584972K032296VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORSJIS2003-08-13
3122881340028402K031924VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1JIT2003-08-07
3122881572343919K030067VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSMJX2003-01-17
3122881711294983K023876VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1JIX2002-12-10
3122881980471652K012561VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLSJJX2001-08-29
3122881114285563K001266VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PACGN2000-05-02
3122881831636938K000566MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORSLTJ2000-03-09
3122881502742895DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total CalibratorsQVP2023-05-05
3122881032100462DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG CalibratorQVP2023-05-05
3122881147309209BP160122
3122881447646257BP050051
3122881468675505BK930030
3122881405723130BK920013
3122881770312845BK890021
3122881250312550BK820003
3122881365394054BK261331
3122881804860260BK251238
3122881291297273BK251237
3122881999795291BK220724
3122881309877319BK130032
3122881053414764

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOM62011-07-20
JJX52004-09-27
JIT32004-12-09
JJY31998-11-04
DHA22024-05-08
CEW22023-09-05
DHX22023-08-23
NIG22023-08-09
QVP22023-05-05
NBC22021-10-04
CIG22019-04-26
DCK22017-07-14
LBS22012-09-07
JLW22008-12-22
LOL22006-09-15
JMO22006-06-15
KLS22004-11-30
LTK12022-12-12
JHX12022-01-28
DLZ12021-08-13
PMT12020-02-25
CIX12019-06-07
CGA12019-04-03
CHH12019-03-27
CDN12019-03-14
JFY12018-10-30
PDJ12015-06-04
CDT12013-05-31
LPS12013-05-15
MRG12013-02-15
JGS12008-06-30
CEM12007-12-07
CJY12007-09-20
DIS12007-01-05
LDJ12006-12-28
JXM12006-12-22
MMI12006-12-19
DJG12006-12-15
DJR12006-11-22
LCM12006-11-22

PMA#

PMN#

GUDID#

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