FDA.reportPublic FDA data

Ortho-Clinical Diagnostics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30071113893007111389Ortho-Clinical Diagnostics1N2026-01-01Felindre Meadows Pencoed Bridgend GB CF35 5PZ
30071113893007111389Ortho-Clinical Diagnostics1N2020-04-25Felindre Meadows Pencoed Bridgend GB CF35 5PZ

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
912901194428649P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLSSEI2011-07-20
3127201385088354P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLSSEI2011-07-20
3127201433667431P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLSLOM2011-05-11
912901626767863P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLSLOM2011-05-11
3127201909123349P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
912902025829461P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
3127201039148954P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
912901552094551P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
912901515368533P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
3127201876315254P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
912901154580414P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNRLOM2001-04-27
3127201385779327P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNRLOM2001-04-27
912901949354375P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
3127202070006446P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
912901034649169K994145VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORSJIS1999-12-22
3127201343396273K994145VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORSJIS1999-12-22
912901003483785K993068VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORSJHX1999-10-04
912901944602936K990984VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERSJJX1999-04-08
912901061904116K990783VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERSJJX1999-03-25
912901286914555K990061VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERSJJX1999-01-25
912901685434583K990016VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLSJJY1999-05-19
912901471787106K984011VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERSJJX1998-12-07
912901419326488K983875VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACKLTK1999-05-14
3127201545196239K983690VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKMOI1999-02-02
912901796596946K983690VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKMOI1999-02-02
912901456653363K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSJMM1999-01-29
3127201956116669K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSJMM1999-01-29
3127201721546618K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
912901834672863K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
912901617994133K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
3127201757233346K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
912901691312843K983031VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAYLOJ1998-12-18
3127201194774061K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
912901286789404K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
3127201796900905K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
912901877816225K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
3127201596089087K973331VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)DBF1997-10-22
912901878771736K973331VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)DBF1997-10-22
3127201522269507K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)CHP1997-03-18
912901548420176K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)CHP1997-03-18
912901773030142K970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSCFT1997-02-25
3127201836532856K965142VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)CEC1997-03-18
912901985033390K965142VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)CEC1997-03-18
912901596002410K965048VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)JJY1997-01-27
912901624135923K964982VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)CEP1997-02-20
3127201845499011K964982VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)CEP1997-02-20
3127201417738613K964721VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)KLI1996-12-18
912901935136376K964721VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)KLI1996-12-18
3127201183794043K964720VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)CGJ1997-02-04
912901709321495K964720VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)CGJ1997-02-04
912901275429483K964310VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)CDP1996-11-27
912901518815476K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)KHQ1996-11-27
3127201378119063K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI2025-10-29
3127201428615879K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA2024-05-08
3127201069340945K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG2023-08-09
3127201791884017K231517VITROS Immunodiagnostic Products CEA Reagent PackDHX2023-08-23
3127201282088727K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK2022-12-12
3127201785280034K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW2023-09-05
3127201088306970K213626VITROS AFPLOJ2022-06-15
3127201294492458K212648VITROS Immunodiagnostic Products CK-MB Reagent PackJHX2022-01-28
3127201133252456K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC2021-10-04
3127201509633778K200236VITROS BRAHMS PCT Reagent Pack and CalibratorsPMT2020-02-25
912901086363258K171168VITROS Immunodiagnostic Products Insulin CalibratorsJIT2017-05-16
3127201858028560K171168VITROS Immunodiagnostic Products Insulin CalibratorsJIT2017-05-16
3127201279267715K121608VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORSMRG2013-02-15
912901648050516K121608VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORSMRG2013-02-15
912901085656562K101921VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VITCEW2010-10-22
3127201650595488K101921VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VITCEW2010-10-22
912901414150294K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMJLW2008-12-22
3127201799775839K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMJLW2008-12-22
912902004180756K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMJLW2008-10-23
912901389338006K063720VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERSDHA2007-04-09
3127201996030432K063720VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERSDHA2007-04-09
3127201251816579K063143VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORSLFX2006-12-26
912902031735733K063143VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORSLFX2006-12-26
3127201452233425K062838VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303MMI2006-12-19
912901883909564K062838VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303MMI2006-12-19
912901350182061K060770VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLSLOL2006-09-15
3127201591700812K060770VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLSLOL2006-09-15
912901828990401K060678VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLSLOL2006-09-14
3127201980739229K060678VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLSLOL2006-09-14
3127201457881243K060632VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158NBC2006-06-06
912901689097847K060632VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158NBC2006-06-06
912901408457079K060480VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLSCGR2006-07-03
3127201772348712K060480VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLSCGR2006-07-03
3127201118348934K052889VITROS CA 19-9NIG2005-12-20
912901406153849K052889VITROS CA 19-9NIG2005-12-20
3127201079970070K042303VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLSJJX2004-09-27
912901655421438K042303VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLSJJX2004-09-27
3127201312314339K041322VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERSDHX2004-06-17
912901346983082K041322VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERSDHX2004-06-17
912901311094380K033300VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERSDDR2003-11-05
3127201722759354K033300VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERSDDR2003-11-05
912901103996891K033127VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLSJJX2003-10-31
3127201523796309K033127VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLSJJX2003-10-31
3127201379237638K032993VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLSJJX2003-10-31
912901755939573K032993VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLSJJX2003-10-31
912901004779288K032296VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORSJIS2003-08-13
3127201481584972K032296VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORSJIS2003-08-13
912901255182918K030067VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSMJX2003-01-17
3127201572343919K030067VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSMJX2003-01-17
912901020998510K013900VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERSJJX2001-12-21
3127201747021500K013899VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORSCDD2002-01-24
912901849336832K013899VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORSCDD2002-01-24
912901539036789K012561VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLSJJX2001-08-29
3127201980471652K012561VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLSJJX2001-08-29
912901992909797K011463VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERSJJX2001-06-13
3127201114285563K001266VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PACGN2000-05-02
912901647027237K001266VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PACGN2000-05-02
3127201831636938K000566MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORSLTJ2000-03-09
912901835704835K000566MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORSLTJ2000-03-09
3127201502742895DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total CalibratorsQVP2023-05-05
3127201032100462DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG CalibratorQVP2023-05-05
3127201147309209BP160122
912901493737254BP160122
912901118934905BP050051
3127201447646257BP050051
912901600549260BK100040
912901188861436
912901256801523

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX162004-09-27
LOM122011-07-20
JJY81999-05-19
LOL42006-09-15
JIS42003-08-13
MMI32025-10-29
DHA32024-05-08
CEW32023-09-05
DHX32023-08-23
NIG32023-08-09
NBC32021-10-04
JLW32008-12-22
QVP22023-05-05
LTK22022-12-12
LOJ22022-06-15
JHX22022-01-28
JIT22017-05-16
MRG22013-02-15
LFX22006-12-26
CGR22006-07-03
DDR22003-11-05
MJX22003-01-17
CDD22002-01-24
MZO22001-08-30
CGN22000-05-02
LTJ22000-03-09
MOI21999-02-02
JMM21999-01-29
DBF21997-10-22
CHP21997-03-18
CEC21997-03-18
CEP21997-02-20
CGJ21997-02-04
KLI21996-12-18
PMT12020-02-25
CFT11997-02-25
KHQ11996-11-27
CDP11996-11-27

PMA#

47 records. Showing 1-40. Next

PMN#