BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Status: Terminated × Clear all

    Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·April 17, 2019

    Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·April 17, 2019

    Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·April 17, 2019

    This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·September 18, 2019

    Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·October 2, 2019

    Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·February 12, 2020

    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·July 27, 2022

    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·July 27, 2022

    CK MB Calibrator, Catalogue Number CK2393

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·May 25, 2022