BEUDAMED
    13 results · 55ms · Sources: EU EUDAMED, US FDA

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    Magnesium on RX Imola analyser IVD

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·December 14, 2016

    Liquid Cardiac Control CQ5053

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·March 21, 2018

    Assayed Bovine Multi-Sera Level 1, Model No. AL1027

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories, Limited·August 14, 2019

    Randox Liquid Cardiac Controls Catalogue Number CQ5052.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·November 27, 2019

    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·August 14, 2019

    RX Imola, Model Nos. RX4900

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·July 31, 2019

    RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories, Limited·November 20, 2019

    RX Daytona, Model Nos. RX4040 and RX4041

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·July 31, 2019

    RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·March 4, 2020

    Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·November 27, 2019

    Randox Liquid Cardiac Controls Catalogue Number CQ5051

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·November 27, 2019

    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories, Limited·January 29, 2025

    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories, Limited·January 29, 2025