FDA.reportPublic FDA data

ORTHO-CLINICAL DIAGNOSTICS, INC.

Matched from indexed company URL: Ortho-Clinical Diagnostics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13196811000136573ORTHO-CLINICAL DIAGNOSTICS, INC.1N2026-01-01100 Indigo Creek Dr Rochester NY US 14626
13198081000305841ORTHO-CLINICAL DIAGNOSTICS, INC.1N2026-01-011000 LEE RD. Rochester NY US 14606
13198091000305840ORTHO-CLINICAL DIAGNOSTICS, INC.1N2026-01-01513 Technology Blvd. ROCHESTER NY US 14626
15284501000122536Ortho-Clinical Diagnostics, Inc.1N2026-01-012005 East State Street, Suite 100 ATHENS OH US 45701
22500512250051ORTHO-CLINICAL DIAGNOSTICS, INC.1N2026-01-011001 US Highway 202 RARITAN NJ US 08869
30003089303000308930Ortho-Clinical Diagnostics European Support Center1N2026-01-011500 Boulevard Sebastien Brant B.P. 30335 Illkirch, CEDEX Bas-Rhin FR 67411
30026423963002642396Ortho Clinical Diagnostics1N2026-01-011 International Business Park, The Synergy #01-11/12 Singapore South West SG 609917
30071113893007111389Ortho-Clinical Diagnostics1N2026-01-01Felindre Meadows Pencoed Bridgend GB CF35 5PZ
30124667843012466784Ortho-Clinical Diagnostics, Inc.1Y2026-01-016005 Freeport Avenue, Suite 130 Memphis TN US 38141
30210906583021090658Ortho-Clinical Diagnostics, Inc.1N2026-01-012285 Rutherford Road Carlsbad CA US 92008
30221599193022159919Ortho-Clinical Diagnostics, Inc. c/o Phoenix Assurance1Y2026-01-014755 Southpoint Drive, Suite 101 Memphis TN US 38118
30300653593030065359Ortho-Clinical Diagnostics, Inc. c/o UPS Supply Chain Solutions1Y2026-01-017 Gateway Blvd. Pedricktown NJ US 08067
30337510963033751096Ortho-Clinical Diagnostics, Inc.1N2026-01-019975 Summers Ridge Rd San Diego CA US 92121
13196811000136573ORTHO-CLINICAL DIAGNOSTICS, INC.1Y2020-04-25100 Indigo Creek Dr Rochester NY US 14626
13198081000305841ORTHO-CLINICAL DIAGNOSTICS, INC.1N2020-04-251000 LEE RD. Rochester NY US 14606
13198091000305840ORTHO-CLINICAL DIAGNOSTICS, INC.1N2020-04-25513 Technology Blvd. ROCHESTER NY US 14626
22500512250051ORTHO-CLINICAL DIAGNOSTICS, INC.1Y2020-04-251001 US Highway 202 RARITAN NJ US 08869
30003089303000308930Ortho-Clinical Diagnostics European Support Center1N2020-04-251500 Boulevard Sebastien Brant B.P. 30335 Illkirch, CEDEX Bas-Rhin FR 67411
30071113893007111389Ortho-Clinical Diagnostics1N2020-04-25Felindre Meadows Pencoed Bridgend GB CF35 5PZ
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
153441194428649P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLSSEI2011-07-20
912901194428649P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLSSEI2011-07-20
3122131385088354P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLSSEI2011-07-20
3122881385088354P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLSSEI2011-07-20
3122901385088354P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLSSEI2011-07-20
3126701385088354P100001VITROS 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
3122131433667431P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLSLOM2011-05-11
3122881433667431P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLSLOM2011-05-11
3122901433667431P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLSLOM2011-05-11
3126701433667431P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLSLOM2011-05-11
3127201433667431P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLSLOM2011-05-11
153441626767863P090028VITROS 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
3122131909123349P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
3122881909123349P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
3122901909123349P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
3126701909123349P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
3127201909123349P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
153442025829461P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
912902025829461P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
3122131039148954P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
3122881039148954P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
3122901039148954P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
3126701039148954P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
3127201039148954P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
153441552094551P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
912901552094551P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
153441515368533P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
912901515368533P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
3122131876315254P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
3122881876315254P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
3122901876315254P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
3126701876315254P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
3127201876315254P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
153441154580414P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNRLOM2001-04-27
912901154580414P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNRLOM2001-04-27
3122131385779327P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNRLOM2001-04-27
3122881385779327P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNRLOM2001-04-27
3122901385779327P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNRLOM2001-04-27
3126701385779327P000044VITROS 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
153441949354375P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
912901949354375P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
3122132070006446P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
3122882070006446P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
3122902070006446P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
3126702070006446P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
3127202070006446P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
153441034649169K994145VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORSJIS1999-12-22
912901034649169K994145VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORSJIS1999-12-22
3122131343396273K994145VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORSJIS1999-12-22
3122901343396273K994145VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORSJIS1999-12-22
3126701343396273K994145VITROS 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
153441003483785K993068VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORSJHX1999-10-04
912901003483785K993068VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORSJHX1999-10-04
153441944602936K990984VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERSJJX1999-04-08
912901944602936K990984VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERSJJX1999-04-08
153441061904116K990783VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERSJJX1999-03-25
912901061904116K990783VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERSJJX1999-03-25
153441286914555K990061VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERSJJX1999-01-25
912901286914555K990061VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERSJJX1999-01-25
153441685434583K990016VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLSJJY1999-05-19
912901685434583K990016VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLSJJY1999-05-19
153441471787106K984011VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERSJJX1998-12-07
912901471787106K984011VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERSJJX1998-12-07
153441419326488K983875VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACKLTK1999-05-14
912901419326488K983875VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACKLTK1999-05-14
3122131545196239K983690VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKMOI1999-02-02
3122881545196239K983690VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKMOI1999-02-02
3122901545196239K983690VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKMOI1999-02-02
3126701545196239K983690VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKMOI1999-02-02
3127201545196239K983690VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKMOI1999-02-02
153441796596946K983690VITROS 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
153441456653363K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSJMM1999-01-29
912901456653363K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSJMM1999-01-29
3122901956116669K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSJMM1999-01-29
3127201956116669K983674VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLSJMM1999-01-29
3122131721546618K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
3122881721546618K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
3122901721546618K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
3126701721546618K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
3127201721546618K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
153441834672863K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
912901834672863K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
153441617994133K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
912901617994133K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
3122131757233346K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
3122881757233346K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
3122901757233346K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
3126701757233346K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
3127201757233346K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
153441691312843K983031VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAYLOJ1998-12-18
912901691312843K983031VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAYLOJ1998-12-18
3126711776148958K981373ALKPHASE-B ASSAY KITCIN1998-05-27
3126711777891829K981364PYRILINKS-D ASSAY KITJMM1998-08-13
3122131194774061K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
3122881194774061K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
3122901194774061K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
3126701194774061K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
3127201194774061K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
153441286789404K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
912901286789404K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
3126712019739078K974111QUIDEL CH50 EQ EIADAE1998-07-29
3336541607911887K974108SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)JJX1997-11-26
2999011998083465K973858CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBOJHI1997-11-26
3336541998083465K973858CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBOJHI1997-11-26
3122131796900905K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
3122881796900905K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
3122901796900905K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
3126701796900905K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
3127201796900905K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
153441877816225K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
912901877816225K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
3122901596089087K973331VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)DBF1997-10-22
3127201596089087K973331VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)DBF1997-10-22
153441878771736K973331VITROS 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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX502004-09-27
LOM422011-07-20
JIT252017-05-16
JJY241999-05-19
DCK212017-07-14
JLW172008-12-22
CIX142019-06-07
CIG142019-04-26
LOL142006-09-15
KLS142004-11-30
LBS132012-09-07
JIS132003-08-13
DHA122024-05-08
NIG122023-08-09
NBC122021-10-04
JMO122006-06-15
CEW112023-09-05
DHX112023-08-23
CDN112019-03-14
JIX112006-04-24
QVP102023-05-05
MMI92025-10-29
CJY92007-09-20
JGP91997-02-18
JJE91995-01-17
DMT91994-03-21
JID91982-04-01
JHI82013-08-02
JGS82008-06-30
CEM82007-12-07
JHS81986-06-27
LTK72022-12-12
JHX72022-01-28
CHH72019-03-27
JFY72018-10-30
GQG72017-02-22
PDJ72015-06-04
CDT72013-05-31
LPS72013-05-15
MRG72013-02-15

PMA#

VITROS Anti-HBc IgM

2023-01-24

Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP030026 Supplement NumberS037 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplemen...

VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator

2023-01-24

Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP090028 Supplement NumberS018 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplemen...

200 records. Showing 1-40. Next

PMN#

176 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next