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

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    Filters Classification: Class Ii ×

    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·April 29, 2020

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022