BEUDAMED
    2 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class I × Clear all

    SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT

    FDA Enforcement
    Class I ·Ongoing·North American Diagnostics·August 10, 2022

    Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE

    FDA Enforcement
    Class I ·Ongoing·Cardinal Health 200, LLC·February 14, 2024