291 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 3, 2017
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 5, 2014
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 5, 2014
VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 7, 2014
VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 7, 2014
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
FDA Enforcement
Class II
·Terminated·ORTHO-CLINICAL DIAGNOSTICS·August 10, 2016
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
FDA Enforcement
Class II
·Terminated·ORTHO-CLINICAL DIAGNOSTICS·April 19, 2017
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.
FDA Enforcement
Class II
·Terminated·ORTHO-CLINICAL DIAGNOSTICS·August 17, 2016
QMS Tacrolimus Calibrators, Product code 10015573
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·January 17, 2024
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·January 1, 2014
VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·October 26, 2016
VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013
VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013