Ortho Clinical Diagnostics

FDA Filings

This page includes the latest FDA filings for Ortho Clinical Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007111389
• FEI Number: 3007111389
• Name: Ortho-Clinical Diagnostics
• Owner & Operator: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Contact Address: 100 INDIGO CREEK DR. --; Rochester NY 14626 US
• Official Correspondent:
  • ANN M QUINN, RAC
  • x-585-4534152-x
• US Agent:
  • ANN M QUINN, RAC
  • ORTHO-CLINICAL DIAGNOSTICS, INC
  • 585 4534152
  • ann.quinn@orthoclinicaldiagnostics.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Felindre Meadows ; Pencoed Bridgend, CF35 5PZ GB
• Establishment Type: Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 20758750035073 ORTHO CLINICAL DIAGNOSTICS	VITROS 6177335	2024-09-26
GUDID 20758750035066 ORTHO CLINICAL DIAGNOSTICS	VITROS 6177334	2024-09-26
GUDID 20758750035059 ORTHO CLINICAL DIAGNOSTICS	VITROS 6177333	2024-09-26
GUDID 20758750034625 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199327	2024-09-26
GUDID 20758750034298 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199334	2024-09-26
GUDID 20758750034915 ORTHO CLINICAL DIAGNOSTICS	VITROS 6177752	2024-05-03
GUDID 20758750034830 ORTHO CLINICAL DIAGNOSTICS	VITROS 6177747	2024-05-03
GUDID 20758750034632 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199328	2024-01-29
GUDID 20758750034304 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199335	2024-01-29
GUDID 20758750032713 ORTHO CLINICAL DIAGNOSTICS	VITROS 6900053	2024-01-29
GUDID 20758750032706 ORTHO CLINICAL DIAGNOSTICS	VITROS 6900052	2024-01-29
GUDID 20758750035462 ORTHO CLINICAL DIAGNOSTICS	VITROS 6174442	2023-11-30
GUDID 20758750034557 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199974	2023-11-30
GUDID 20758750033635 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199954	2023-11-30
GUDID 20758750033628 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199953	2023-11-30
GUDID 20758750033611 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199952	2023-11-30
GUDID 20758750033604 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199951	2023-11-30
MICRhoGAM Ultra-Filtered PLUS Kedrion Biopharma Inc, Ortho Clinical Diagnostics, Kedrion Biopharma Inc.	Other Medication	2023-10-26
GUDID 10758750032044 ORTHO CLINICAL DIAGNOSTICS	VITROS 6844426	2023-07-20
GUDID 10758750033324 ORTHO CLINICAL DIAGNOSTICS	VITROS 6192257	2023-06-21
GUDID 10758750032099 ORTHO CLINICAL DIAGNOSTICS	VITROS 6844507	2023-06-21
GUDID 10758750032068 ORTHO CLINICAL DIAGNOSTICS	VITROS 6844425	2023-06-21
GUDID 10758750032051 ORTHO CLINICAL DIAGNOSTICS	VITROS 6844424	2023-06-21
GUDID 10758750032037 ORTHO CLINICAL DIAGNOSTICS	VITROS 6844423	2023-06-21
GUDID 10758750030217 ORTHO CLINICAL DIAGNOSTICS	VITROS 6844056	2023-06-21
GUDID 10758750030200 ORTHO CLINICAL DIAGNOSTICS	VITROS 6844055	2023-06-21
GUDID 10758750009541 ORTHO CLINICAL DIAGNOSTICS	VITROS 1681543	2023-06-21
GUDID 10758750009404 ORTHO CLINICAL DIAGNOSTICS	VITROS 1614965	2023-06-21
GUDID 10758750009237 ORTHO CLINICAL DIAGNOSTICS	VITROS 1513266	2023-06-21
GUDID 10758750009145 ORTHO CLINICAL DIAGNOSTICS	VITROS 1471481	2023-06-21
GUDID 10758750008995 ORTHO CLINICAL DIAGNOSTICS	VITROS 1393396	2023-06-21
GUDID 10758750008834 ORTHO CLINICAL DIAGNOSTICS	VITROS 1322528	2023-06-21
GUDID 10758750005147 ORTHO CLINICAL DIAGNOSTICS	VITROS 8744468	2023-06-21
GUDID 10758750004997 ORTHO CLINICAL DIAGNOSTICS	VITROS 8536195	2023-06-21
GUDID 10758750004799 ORTHO CLINICAL DIAGNOSTICS	VITROS 8356636	2023-06-21
GUDID 10758750004614 ORTHO CLINICAL DIAGNOSTICS	VITROS 8254898	2023-06-21
GUDID 10758750004546 ORTHO CLINICAL DIAGNOSTICS	VITROS 8209074	2023-06-21
GUDID 10758750002511 ORTHO CLINICAL DIAGNOSTICS	VITROS 6802302	2023-06-21
GUDID 10758750002351 ORTHO CLINICAL DIAGNOSTICS	VITROS 6802241	2023-06-21
GUDID 10758750002337 ORTHO CLINICAL DIAGNOSTICS	VITROS 6802221	2023-06-21
GUDID 10758750002320 ORTHO CLINICAL DIAGNOSTICS	VITROS 6802220	2023-06-21
GUDID 10758750002078 ORTHO CLINICAL DIAGNOSTICS	VITROS 6802157	2023-06-21
GUDID 10758750001477 ORTHO CLINICAL DIAGNOSTICS	VITROS 6801823	2023-06-21
GUDID 10758750001415 ORTHO CLINICAL DIAGNOSTICS	VITROS 6801812	2023-06-21
GUDID 10758750001323 ORTHO CLINICAL DIAGNOSTICS	VITROS 6801758	2023-06-21
GUDID 10758750001316 ORTHO CLINICAL DIAGNOSTICS	VITROS 6801757	2023-06-21
GUDID 10758750001286 ORTHO CLINICAL DIAGNOSTICS	VITROS 6801462	2023-06-21
GUDID 10758750001026 ORTHO CLINICAL DIAGNOSTICS	VITROS 6801043	2023-06-21
GUDID 10758750001019 ORTHO CLINICAL DIAGNOSTICS	VITROS 6801042	2023-06-21
GUDID 10758750000968 ORTHO CLINICAL DIAGNOSTICS	VITROS 6800876	2023-06-21
GUDID 10758750000913 ORTHO CLINICAL DIAGNOSTICS	VITROS 6800863	2023-06-21
GUDID 10758750000876 ORTHO CLINICAL DIAGNOSTICS	VITROS 6800784	2023-06-21
GUDID 10758750000555 ORTHO CLINICAL DIAGNOSTICS	VITROS 6800035	2023-06-21
GUDID 10758750000548 ORTHO CLINICAL DIAGNOSTICS	VITROS 6800034	2023-06-21
GUDID 10758750000531 ORTHO CLINICAL DIAGNOSTICS	VITROS 6800033	2023-06-21
GUDID 10758750000258 ORTHO CLINICAL DIAGNOSTICS	VITROS 1920115	2023-06-21
GUDID 10758750000227 ORTHO CLINICAL DIAGNOSTICS	VITROS 1912997	2023-06-21
GUDID 10758750000210 ORTHO CLINICAL DIAGNOSTICS	VITROS 1901263	2023-06-21
GUDID 10758750000203 ORTHO CLINICAL DIAGNOSTICS	VITROS 1896836	2023-06-21
GUDID 10758750000029 ORTHO CLINICAL DIAGNOSTICS	VITROS 1728872	2023-06-21
GUDID 20758750009081 ORTHO CLINICAL DIAGNOSTICS	VITROS 1435866	2023-05-22
GUDID 20758750005083 ORTHO CLINICAL DIAGNOSTICS	VITROS 8642712	2023-05-22
GUDID 10758750009213 ORTHO CLINICAL DIAGNOSTICS	VITROS 1487289	2023-04-26
GUDID 10758750008971 ORTHO CLINICAL DIAGNOSTICS	VITROS 1387000	2023-04-26
GUDID 10758750008926 ORTHO CLINICAL DIAGNOSTICS	VITROS 1372101	2023-04-26
GUDID 10758750008810 ORTHO CLINICAL DIAGNOSTICS	VITROS 1318930	2023-04-26
GUDID 10758750008797 ORTHO CLINICAL DIAGNOSTICS	VITROS 1315589	2023-04-26
GUDID 10758750008766 ORTHO CLINICAL DIAGNOSTICS	VITROS 1311075	2023-04-26
GUDID 10758750008742 ORTHO CLINICAL DIAGNOSTICS	VITROS 1306026	2023-04-26
GUDID 10758750008728 ORTHO CLINICAL DIAGNOSTICS	VITROS 1286293	2023-04-26
GUDID 10758750008551 ORTHO CLINICAL DIAGNOSTICS	VITROS 1209733	2023-04-26
GUDID 10758750008506 ORTHO CLINICAL DIAGNOSTICS	VITROS 1158864	2023-04-26
GUDID 10758750008445 ORTHO CLINICAL DIAGNOSTICS	VITROS 1113596	2023-04-26
GUDID 10758750008438 ORTHO CLINICAL DIAGNOSTICS	VITROS 1112820	2023-04-26
GUDID 10758750008407 ORTHO CLINICAL DIAGNOSTICS	VITROS 1107804	2023-04-26
GUDID 10758750008384 ORTHO CLINICAL DIAGNOSTICS	VITROS 1090133	2023-04-26
GUDID 10758750008377 ORTHO CLINICAL DIAGNOSTICS	VITROS 1074053	2023-04-26
GUDID 10758750008353 ORTHO CLINICAL DIAGNOSTICS	VITROS 1062306	2023-04-26
GUDID 10758750033867 ORTHO CLINICAL DIAGNOSTICS	VITROS 6808896	2023-04-05
GUDID 10758750033850 ORTHO CLINICAL DIAGNOSTICS	VITROS 6808895	2023-04-05
GUDID 10758750033843 ORTHO CLINICAL DIAGNOSTICS	VITROS 6808894	2023-04-05
GUDID 10758750033805 ORTHO CLINICAL DIAGNOSTICS	VITROS 6808890	2023-04-05
GUDID 10758750033799 ORTHO CLINICAL DIAGNOSTICS	VITROS 6808889	2023-04-05
GUDID 10758750033782 ORTHO CLINICAL DIAGNOSTICS	VITROS 6808888	2023-04-05
GUDID 10758750034901 ORTHO CLINICAL DIAGNOSTICS	VITROS 6177751	2023-03-22
GUDID 10758750034826 ORTHO CLINICAL DIAGNOSTICS	VITROS 6177746	2023-03-22
MICRhoGAM Ultra-Filtered PLUS Kedrion Biopharma Inc, Ortho Clinical Diagnostics, Kedrion Biopharma Inc.	Other Medication	2023-01-11
MICRhoGAM Ultra-Filtered PLUS Kedrion Biopharma Inc, Ortho Clinical Diagnostics, Kedrion Biopharma Inc.	Other Medication	2022-12-22
GUDID 10758750034642 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199329	2022-11-03
GUDID 10758750034895 ORTHO CLINICAL DIAGNOSTICS	VITROS 6177750	2022-11-01
GUDID 10758750034819 ORTHO CLINICAL DIAGNOSTICS	VITROS 6177745	2022-11-01
GUDID 10758750034659 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199330	2022-11-01
GUDID 10758750034321 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199337	2022-11-01
GUDID 10758750034314 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199336	2022-11-01
GUDID 10758750033317 ORTHO CLINICAL DIAGNOSTICS	VITROS 6192256	2022-11-01
PMN K213626 Ortho Clinical Diagnostics	VITROS AFP	2022-06-15
PMN K212648 Ortho Clinical Diagnostics	VITROS Immunodiagnostic Products CK-MB Reagent Pack	2022-01-28
GUDID 10758750000517 ORTHO CLINICAL DIAGNOSTICS	VITROS 6800031	2021-12-08
GUDID 10758750034420 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199961	2021-11-16
GUDID 10758750034413 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199960	2021-11-16
GUDID 10758750033300 ORTHO CLINICAL DIAGNOSTICS	VITROS 6192255	2021-11-16
GUDID 10758750033195 ORTHO CLINICAL DIAGNOSTICS	VITROS 691 2265	2021-11-16
GUDID 10758750033171 ORTHO CLINICAL DIAGNOSTICS	VITROS 691 2263	2021-11-16
GUDID 10758750033164 ORTHO CLINICAL DIAGNOSTICS	VITROS 691 2261	2021-11-16
PMN K201312 Ortho Clinical Diagnostics	VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack	2021-10-04
GUDID 10758750033355 ORTHO CLINICAL DIAGNOSTICS	VITROS 6199919	2021-03-30
MICRhoGAM Ultra-Filtered PLUS Kedrion Biopharma Inc, Ortho Clinical Diagnostics, Kedrion Biopharma Inc.	Other Medication	2021-02-12
PMN K200236 Ortho Clinical Diagnostics	VITROS BRAHMS PCT Reagent Pack And Calibrators	2020-02-25
MICRhoGAM Ultra-Filtered PLUS Kedrion Biopharma Inc, Ortho Clinical Diagnostics, Kedrion Biopharma Inc.	Other Medication	2019-10-05
PMA P100001S016 ORTHO-CLINICAL DIAGNOSTICS	VITROS Anti-HBe	2019-06-19
PMA P030024S029 ORTHO-CLINICAL DIAGNOSTICS	VITROS Anti-HBc	2019-06-19
JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	Total Thyroid Controls	2019-06-18
JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	Free Thyroid Controls	2019-06-18
PMN BP160122 | MZF Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostics Product HIV Combo Reagent Pack	2019-06-13
PMN BP160122 | MZF Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostics Product HIV Combo Calibrator	2019-06-13
PMA P100001S015 ORTHO-CLINICAL DIAGNOSTICS	VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator	2018-12-17
PMA P030024S028 ORTHO-CLINICAL DIAGNOSTICS	VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator	2018-12-17
PMA P030024S027 ORTHO-CLINICAL DIAGNOSTICS	VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator	2018-10-16
PMA P100001S014 ORTHO-CLINICAL DIAGNOSTICS	VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator	2018-07-02
PMA P100001S012 ORTHO-CLINICAL DIAGNOSTICS	VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator	2018-07-02
PMA P030024S026 ORTHO-CLINICAL DIAGNOSTICS	VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator	2018-07-02
PMA P030024S025 ORTHO-CLINICAL DIAGNOSTICS	VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator	2018-07-02
PMA P100001S013 ORTHO-CLINICAL DIAGNOSTICS	Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator	2018-02-16
JKD Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS C-peptide Reagent Pack	2017-12-13
JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS C-peptide Calibrators	2017-12-13
PMN K171168 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Insulin Calibrators	2017-11-15
PMN K163433 Ortho Clinical Diagnostics	VITROS Chemistry Products GLU Slides	2017-09-18
PMA P100001S011 ORTHO-CLINICAL DIAGNOSTICS	VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator	2017-09-15
PMA P100001S010 ORTHO-CLINICAL DIAGNOSTICS	VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS	2017-09-12
PMA P030024S024 ORTHO-CLINICAL DIAGNOSTICS	VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator	2017-09-01
CFP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Insulin Reagent Pack	2017-07-25
PMN K160712 Ortho Clinical Diagnostics	VITROS Chemistry Products HsCRP Reagent	2017-07-14
PMN K171168 Ortho Clinical Diagnostics	VITROS Immunodiagnostic Products Insulin Calibrators	2017-05-16
PMN K162020 Ortho Clinical Diagnostics	VITROS Chemistry Products Cl- Slides	2016-12-16
PMA P100001S009 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR	2016-10-10
PMN K152433 ORTHO CLINICAL DIAGNOSTICS	VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7	2015-09-24
PMA P100001S008 ORTHO-CLINICAL DIAGNOSTICS	VITROS ANTI-HBE ASSAY	2015-09-08
PMA P030024S023 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR	2015-09-08
PMA P100001S007 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR	2015-07-23
PMA P030024S022 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR	2015-07-23
PMN K142595 ORTHO CLINICAL DIAGNOSTICS	VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I And II	2015-06-04
PMA P100001S006 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR	2013-10-17
PMA P030024S021 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR	2013-09-06
PMN K121608 | MRG Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 25-OH Vitamin D Total Reagent Pack, 6844056	2013-05-22
PMN K121608 | MRG Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 25-OH Vitamin D Total Calibrator, 6844055	2013-05-22
PMN K121608 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 25-OH Vitamin D Total Reagent Pack, 6844056	2013-05-22
PMN K121608 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 25-OH Vitamin D Total Calibrator, 6844055	2013-05-22
PMA P100001S005 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE	2012-12-21
PMA P100001S004 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR	2012-11-19
PMA P100001S003 ORTHO-CLINICAL DIAGNOSTICS	VITROS ANTI-HBE	2012-11-13
PMA P030024S020 ORTHO-CLINICAL DIAGNOSTICS	VITROS ANTI-HBC	2012-11-13
PMA P100001S002 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR	2012-10-17
PMA P030024S019 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR	2012-05-24
PMA P100001S001 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR	2012-04-16
PMA P030024S018 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR	2012-02-23
PMA P030024S017 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC ASSAY	2011-11-10
PMN K964982 | CEP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS LH Reagent Pack & Calibrator	2011-10-25
PMN K013900 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS B12 Range Verifiers	2011-10-25
PMN K012561 | MJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HCV Controls	2011-10-25
PMN K012561 | MJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HCV Controls	2011-10-25
PMN K012561 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HCV Controls	2011-10-25
PMN K011463 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Folate Range Verifiers	2011-10-17
PMN P100001 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HBe Reagent Pack, Calibrator and Controls	2011-07-27
PMN P090028 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS HBeAg Reagent Pack	2011-07-27
PMN P090028 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS HBeAg Controls	2011-07-27
PMN P090028 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS HBeAg Calibrator	2011-07-27
PMN K101921 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Reagent	2011-02-17
PMN K101921 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Range Verifiers	2011-02-17
PMN K101921 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Controls	2011-02-17
PMN K101921 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Calibrators	2011-02-17
PMN K101921 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Reagent	2011-02-17
PMN K101921 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Range Verifiers	2011-02-17
PMN K101921 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Controls	2011-02-17
PMN K101921 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Calibrators	2011-02-17
PMN K101921 | CEW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Reagent	2011-02-17
PMN K101921 | CEW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Range Verifiers	2011-02-17
PMN K101921 | CEW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Controls	2011-02-17
PMN K101921 | CEW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS iPTH Calibrators	2011-02-17
PMN P030026 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HBc IgM Reagent Pack	2010-11-19
PMN P030026 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HBc IgM Calibrator	2010-11-19
PMN P030024 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HBc Reagent Pack	2010-11-19
PMN P030024 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HBc Calibrator	2010-11-19
PMN P000044 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS HBsAg Reagent Pack	2010-11-19
PMN P000044 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS HBsAg Confirmatory Kit	2010-11-19
PMN P000044 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS HBsAg Calibrator	2010-11-19
PMN K994145 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Free T3 Reagent Pack & Calibrator	2010-11-19
PMN K990984 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CEA Range Verifiers	2010-11-19
PMN K990783 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS PSA Range Verifiers	2010-11-19
PMN K990783 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 15-3 Range Verifiers	2010-11-19
PMN K990783 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 125II Range Verifiers	2010-11-19
PMN K990061 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS AFP Range Verifiers	2010-11-19
PMN K990016 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anemia Controls	2010-11-19
PMN K984011 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Cortisol Range Verifiers	2010-11-19
PMN K983513 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Range Verifiers	2010-11-19
PMN K983513 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NTx Range Verifiers	2010-11-19
PMN K974644 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Free T4 Range Verifiers	2010-11-19
PMN K974644 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Ferritin Range Verifiers	2010-11-19
PMN K974644 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Estradiol Range Verifiers	2010-11-19
PMN K974644 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CK-MB Range Verifiers	2010-11-19
PMN K973517 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total T4 Range Verifiers	2010-11-19
PMN K973517 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TSH Range Verifiers	2010-11-19
PMN K973517 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS T3 Uptake Range Verifiers	2010-11-19
PMN K973517 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Prolactin Range Verifiers	2010-11-19
PMN K973517 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Progesterone Range Verifiers	2010-11-19
PMN K973517 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS LH Range Verifiers	2010-11-19
PMN K973517 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS FT3 Range Verifiers	2010-11-19
PMN K973517 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS FSH Range Verifiers	2010-11-19
PMN K973517 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITRO Total T3 Range Verifiers	2010-11-19
PMN K970643 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS E2 Reagent Pack	2010-11-19
PMN K970643 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS E2 Calibrator	2010-11-19
PMN K970643 | CHP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS E2 Reagent Pack	2010-11-19
PMN K970643 | CHP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS E2 Calibrator	2010-11-19
PMN K965048 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS RE Controls	2010-11-19
PMN K964720 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS FSH Reagent Pack	2010-11-19
PMN K964720 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS FSH Calibrator	2010-11-19
PMN K964720 | CGJ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS FSH Reagent Pack	2010-11-19
PMN K964720 | CGJ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS FSH Calibrator	2010-11-19
PMN K964308 | KHQ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS T3U Reagent Pack	2010-11-19
PMN K964308 | KHQ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS T3U Calibrator	2010-11-19
PMN K964308 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS T3U Reagent Pack	2010-11-19
PMN K964308 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS T3U Calibrator	2010-11-19
PMN K062838 | MMI Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TropI ES Reagent Pack	2010-11-19
PMN K062838 | MMI Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TropI ES Range Verifiers	2010-11-19
PMN K062838 | MMI Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TropI ES Calibrator	2010-11-19
PMN K062838 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TropI ES Reagent Pack	2010-11-19
PMN K062838 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TropI ES Range Verifiers	2010-11-19
PMN K062838 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TropI ES Calibrator	2010-11-19
PMN K062838 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TropI ES Reagent Pack	2010-11-19
PMN K062838 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TropI ES Range Verifiers	2010-11-19
PMN K062838 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS TropI ES Calibrator	2010-11-19
PMN K060770 | LOL Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HAV IgM Reagent Pack, Calibrator & Controls	2010-11-19
PMN K060480 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Metabolism Controls	2010-11-19
PMN K060480 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Cortisol Reagent Pack	2010-11-19
PMN K060480 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Cortisol Calibrator	2010-11-19
PMN K060480 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Metabolism Controls	2010-11-19
PMN K060480 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Cortisol Reagent Pack	2010-11-19
PMN K060480 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Cortisol Calibrator	2010-11-19
PMN K060480 | CGR Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Metabolism Controls	2010-11-19
PMN K060480 | CGR Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Cortisol Reagent Pack	2010-11-19
PMN K060480 | CGR Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Cortisol Calibrator	2010-11-19
PMN K042303 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HBs Controls	2010-11-19
PMN K033127 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HBc Controls	2010-11-19
PMN K000566 | LTJ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS PSA Reagent Pack & Calibrator	2010-11-19
PMN BK100040 | OHQ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HIV 1+2 Controls	2010-11-19
PMN K101921 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT	2010-10-22
PMN K083173 | JLW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Reagent Pack	2010-01-18
PMN K083173 | JLW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Calibrator	2010-01-18
PMN K083173 | JLW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 3600 System & Refurbished	2010-01-18
PMN K083173 | JJE Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Reagent Pack	2010-01-18
PMN K083173 | JJE Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Calibrator	2010-01-18
PMN K083173 | JJE Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 3600 System & Refurbished	2010-01-18
PMN K083173 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Reagent Pack	2010-01-18
PMN K083173 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Calibrator	2010-01-18
PMN K083173 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 3600 System & Refurbished	2010-01-18
PMN K081543 | JLW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Reagent Pack	2010-01-18
PMN K081543 | JLW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Calibrator	2010-01-18
PMN K081543 | JLW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Chemistry Products PHYT Slides	2010-01-18
PMN K081543 | JLW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Chemistry Products Calibrator Kit 9	2010-01-18
PMN K081543 | JLW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 5600 System	2010-01-18
PMN K081543 | JLW Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 5600 System Refurbished	2010-01-18
PMN K081543 | JJE Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Reagent Pack	2010-01-18
PMN K081543 | JJE Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Calibrator	2010-01-18
PMN K081543 | JJE Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Chemistry Products PHYT Slides	2010-01-18
PMN K081543 | JJE Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Chemistry Products Calibrator Kit 9	2010-01-18
PMN K081543 | JJE Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 5600 System	2010-01-18
PMN K081543 | JJE Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 5600 System Refurbished	2010-01-18
PMN K081543 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Reagent Pack	2010-01-18
PMN K081543 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Calibrator	2010-01-18
PMN K081543 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Chemistry Products PHYT Slides	2010-01-18
PMN K081543 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Chemistry Products Calibrator Kit 9	2010-01-18
PMN K081543 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 5600 System	2010-01-18
PMN K081543 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 5600 System Refurbished	2010-01-18
PMN K081543 | DIP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Reagent Pack	2010-01-18
PMN K081543 | DIP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Immunodiagnostic Products TSH Calibrator	2010-01-18
PMN K081543 | DIP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Chemistry Products PHYT Slides	2010-01-18
PMN K081543 | DIP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Chemistry Products Calibrator Kit 9	2010-01-18
PMN K081543 | DIP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 5600 System	2010-01-18
PMN K081543 | DIP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 5600 System Refurbished	2010-01-18
PMN K964310 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total T3 Reagent	2009-12-04
PMN K964310 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total T3 Calibrator	2009-12-04
PMN K964310 | CDP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total T3 Reagent	2009-12-04
PMN K964310 | CDP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total T3 Calibrator	2009-12-04
PMN K083173 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM	2008-12-22
PMN BP050051 | MZF Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS aHIV 1+2 Reagent Pack & Calibrator	2008-04-21
PMN K965142 | CEC Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Free T4 Reagent Pack & Calibrators	2008-03-12
PMN K964721 | KLI Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total T4 Reagent Pack	2008-03-12
PMN K964721 | KLI Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total T4 Calibrator	2008-03-12
PMN K964721 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total T4 Reagent Pack	2008-03-12
PMN K964721 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total T4 Calibrator	2008-03-12
PMN K063720 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS	2007-04-09
PMN K063143 | LFX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Rubella IgG Reagent Pack and Calibrator	2007-01-17
PMN K062165 ORTHO-CLINICAL DIAGNOSTICS	VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS	2007-01-05
PMN K062838 ORTHO-CLINICAL DIAGNOSTICS	VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303	2006-12-19
PMN K060678 | LOL Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HAV Total Reagent Pack, Calibrator and Controls	2006-09-27
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Urine Electrlyte Diluent	2006-09-20
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Universal Wash Reagent	2006-09-20
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Signal Reagent	2006-09-20
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Reference Fluids	2006-09-20
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS ImmunoWash Fluid	2006-09-20
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS High Sample Diluents	2006-09-20
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS FS Reconstitution Diluent	2006-09-20
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS FS Diluent Packs	2006-09-20
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS 7% BSA	2006-09-20
PPM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	Ortho 7% BSA	2006-09-20
PMN K060480 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS	2006-07-03
PMN K060632 | NBC Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NT-proBNP Reagent	2006-06-23
PMN K060632 | NBC Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NT-proBNP Range Verifiers	2006-06-23
PMN K060632 | NBC Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NT-proBNP Calibrators	2006-06-23
PMN K060632 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NT-proBNP Reagent	2006-06-23
PMN K060632 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NT-proBNP Range Verifiers	2006-06-23
PMN K060632 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NT-proBNP Calibrators	2006-06-23
PMN K060632 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NT-proBNP Reagent	2006-06-23
PMN K060632 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NT-proBNP Range Verifiers	2006-06-23
PMN K060632 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NT-proBNP Calibrators	2006-06-23
PMN K052889 | NIG Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 19-9 Reagent Pack	2006-02-27
PMN K052889 | NIG Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 19-9 Range Verifiers	2006-02-27
PMN K052889 | NIG Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 19-9 Calibrator	2006-02-27
PMN K052889 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 19-9 Reagent Pack	2006-02-27
PMN K052889 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 19-9 Range Verifiers	2006-02-27
PMN K052889 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 19-9 Calibrator	2006-02-27
PMN K052889 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 19-9 Reagent Pack	2006-02-27
PMN K052889 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 19-9 Range Verifiers	2006-02-27
PMN K052889 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA 19-9 Calibrator	2006-02-27
PMN K052645 ORTHO-CLINICAL DIAGNOSTICS	VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;	2005-12-14
PMN K042494 ORTHO-CLINICAL DIAGNOSTICS	VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III	2004-10-19
PMN K042303 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS	2004-09-27
PMN K041764 ORTHO-CLINICAL DIAGNOSTICS	THE VITROS 5,1 FS CHEMISTRY SYSTEM	2004-09-09
PMN K033300 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Myoglobin Reagent Pack	2003-12-17
PMN K033300 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Myoglobin Range Verifiers	2003-12-17
PMN K033300 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Myoglobin Calibrator	2003-12-17
PMN K033300 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Myoglobin Reagent Pack	2003-12-17
PMN K033300 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Myoglobin Range Verifiers	2003-12-17
PMN K033300 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Myoglobin Calibrator	2003-12-17
PMN K033300 | DDR Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Myoglobin Reagent Pack	2003-12-17
PMN K033300 | DDR Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Myoglobin Range Verifiers	2003-12-17
PMN K033300 | DDR Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Myoglobin Calibrator	2003-12-17
PMN K033127 ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS	2003-10-31
PMN K030067 | MJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS HBsAg Controls	2003-07-10
PMN P010021 | MZO Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HCV Reagent Pack	2001-10-05
PMN P010021 | MZO Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HCV Calibrator	2001-10-05
PMN P000014 | LOM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HBs Quantitative Reagent Pack & Calibrator	2001-02-22
PMN K001266 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Red Cell Folate Pack	1999-10-05
PMN K001266 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Folate Reagent Pack 1/2	1999-10-05
PMN K001266 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Folate Calibrators	1999-10-05
PMN K001266 | CGN Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Red Cell Folate Pack	1999-10-05
PMN K001266 | CGN Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Folate Reagent Pack 1/2	1999-10-05
PMN K001266 | CGN Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Folate Calibrators	1999-10-05
PMN K041322 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CEA Reagent Pack	1999-06-29
PMN K041322 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CEA Calibrator	1999-06-29
PMN K041322 | DHX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CEA Reagent Pack	1999-06-29
PMN K041322 | DHX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CEA Calibrator	1999-06-29
PMN K983875 | LTK Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA125 Reagent Pack	1999-05-24
PMN K983875 | LTK Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA125 Calibrators	1999-05-24
PMN K983690 | MOI Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CA15-3 Reagent Pack & Calibrator	1999-03-23
PMN K983674 | JMM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NTx Reagent Pack	1999-03-01
PMN K983674 | JMM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NTx Controls	1999-03-01
PMN K983674 | JMM Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS NTx Calibrators	1999-03-01
PMN K032993 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Anti-HBc IgM Controls	1999-03-01
PMN K013899 | CDD Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS B12 Reagent Pack	1999-03-01
PMN K013899 | CDD Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS B12 Folate Reagent Pack 3	1999-03-01
PMN K013899 | CDD Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS B12 Calibrators	1999-03-01
PMN K983031 | LOJ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS AFP Reagent Pack & Calibrator	1999-01-20
PMN K993068 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CK-MB Reagent Pack	1997-11-18
PMN K993068 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CK-MB Calibrator	1997-11-18
PMN K993068 | JHX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CK-MB Reagent Pack	1997-11-18
PMN K993068 | JHX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS CK-MB Calibrator	1997-11-18
PMN K983507 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Reagent Pack	1997-11-18
PMN K983507 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Controls	1997-11-18
PMN K983507 | JJY Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Calibrator	1997-11-18
PMN K983507 | JIX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Reagent Pack	1997-11-18
PMN K983507 | JIX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Controls	1997-11-18
PMN K983507 | JIX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Calibrator	1997-11-18
PMN K983507 | CDZ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Reagent Pack	1997-11-18
PMN K983507 | CDZ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Controls	1997-11-18
PMN K983507 | CDZ Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Testosterone Calibrator	1997-11-18
PMN K973331 | DBF Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Ferritin Reagent Pack	1997-11-18
PMN K973331 | DBF Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Ferritin Calibrators	1997-11-18
PMN K970281 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Prolactin Reagent Pack	1997-11-18
PMN K970281 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Prolactin Calibrator	1997-11-18
PMN K970281 | CFT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Prolactin Reagent Pack	1997-11-18
PMN K970281 | CFT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Prolactin Calibrator	1997-11-18
PMN K063720 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total bhCG II Reagent Pack	1997-11-18
PMN K063720 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total bhCG II Range Verifiers	1997-11-18
PMN K063720 | JJX Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total bhCG II Calibrator	1997-11-18
PMN K063720 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total bhCG II Reagent Pack	1997-11-18
PMN K063720 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total bhCG II Range Verifiers	1997-11-18
PMN K063720 | JIT Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total bhCG II Calibrator	1997-11-18
PMN K063720 | DHA Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total bhCG II Reagent Pack	1997-11-18
PMN K063720 | DHA Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total bhCG II Range Verifiers	1997-11-18
PMN K063720 | DHA Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Total bhCG II Calibrator	1997-11-18
PMN K032296 | JIS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Progesterone Reagent Pack & Calibrators	1997-11-18
JLS Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS Progesterone Reagent Pack & Calibrator	1994-05-23
CEP Ortho-Clinical Diagnostics [ORTHO-CLINICAL DIAGNOSTICS, INC.]	VITROS LH Reagent Pack & Calibrator	1994-05-23

Similar & Related FDA Registered Companies

• Ortho-Clinical Diagnostics, Inc.
• 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 Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• 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 Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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• Kedrion Biopharma Inc

Related Finance Registrations

NCAGE Code	KCAG1	ORTHO-CLINICAL DIAGNOSTICS
NCAGE Code	EUD94	ORTHO-CLINICAL DIAGNOSTICS
NCAGE Code	U7254	ORTHO-CLINICAL DIAGNOSTICS DBA LIFESCAN
CAGE Code	EUD94	ORTHO-CLINICAL DIAGNOSTICS
CAGE Code	KCAG1	ORTHO-CLINICAL DIAGNOSTICS
CAGE Code	U7254	ORTHO-CLINICAL DIAGNOSTICS DBA LIFESCAN LIFESCAN
S.A.M. Registration	U7254 [763632692]	ORTHO-CLINICAL DIAGNOSTICS LIFESCAN

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092856910	Felixstowe ,United Kingdom -> Savannah, Georgia	OF MEDICAL DIAGNOSTIC REAGENTS ALL PACKED ONTO 11 PALLETS GENSET REQUIRED AND RUNNING ON ARRIVAL TEMPERATURE CONTROLLED CARGO AT PLUS 5 DEGS C	555 BOX
20200926867	Felixstowe ,United Kingdom -> Savannah, Georgia	OF MEDICAL DIAGNOSTIC REAGENTS ALL PACKED ONTO 14 PALLETS GENSET REQUIRED AND RUNNING ON ARRIVAL TEMPERATURE CONTROLLED CARGO AT PLUS 5 DEGS C	732 BOX
20200926405	Felixstowe ,United Kingdom -> Savannah, Georgia	OF MEDICAL DIAGNOSTIC REAGENTS ALL PACKED ONTO 20 PALLETS GENSET REQUIRED AND RUNNING ON ARRIVAL TEMPERATURE CONTROLLED CARGO AT PLUS 5 DEGS C	1043 BOX
2020092235284	Felixstowe ,United Kingdom -> Savannah, Georgia	OF MEDICAL DIAGNOSTIC REAGENTS ALL PACKED ONTO 17 PALLETS GENSET REQUIRED AND RUNNING ON ARRIVAL TEMPERATURE CONTROLLED CARGO AT PLUS 5 DEGS C	884 BOX
2020092256556	Felixstowe ,United Kingdom -> Savannah, Georgia	OF MEDICAL DIAGNOSTIC REAGENTS ALL PACKED ONTO 13 PALLETS GENSET REQUIRED AND RUNNING ON ARRIVAL TEMPERATURE CONTROLLED CARGO AT PLUS 5 DEGS C	671 BOX
2020092135671	Felixstowe ,United Kingdom -> Savannah, Georgia	OF MEDICAL DIAGNOSTIC REAGENTS ALL PACKED ONTO 17 PALLETS GENSET REQUIRED AND RUNNING ON ARRIVAL TEMPERATURE CONTROLLED CARGO AT PLUS 5 DEGS C	884 BOX