BEUDAMED
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    Filters Classification: Class Ii ×

    VITROS XT Chemistry Products ALKP Slides

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·September 27, 2023

    VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics, Inc.·January 13, 2021

    VITROS XT Chemistry Products TBIL-ALKP Slides

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·September 27, 2023

    VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    FDA Enforcement
    Class II ·Ongoing·Ortho Clinical Diagnostics Inc·January 13, 2021

    enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics, Inc.·January 13, 2021

    Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·February 27, 2019

    VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·November 25, 2020

    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·November 25, 2020

    VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. For emergency authorization use only (EAU). Product Code: 6199941. OUS Product.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics, Inc.·March 24, 2021

    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199966

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·October 27, 2021

    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc·May 25, 2022

    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc·May 25, 2022

    VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·June 7, 2023

    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·September 14, 2022

    VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc·May 25, 2022

    VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·January 20, 2021

    VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023

    VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·January 20, 2021

    VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023

    VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023