BEUDAMED
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    JOTEC GmbH

    Authorized representative
    🇩🇪 Germany·2 Manufacturers

    CTX-M β-lactamases Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device

    IDS Beta CrossLaps® (CTX-I)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·3 devices

    IDS-iSYS CTX-I (CrossLaps®)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·2 devices

    Urine CartiLaps® (CTX-II) EIA

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·1 device

    Alpha CrossLaps® (CTX-I) ELISA

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·1 device

    Urine CrossLaps® (CTX-I) EIA

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·1 device

    Serum CrossLaps® (CTX-I) ELISA

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Immunodiagnostic Systems Limited·1 device

    Cyclosporine

    FDA Pre-Market Approval
    FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    FDA Pre-Market Approval
    FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

    Enzyme Immunoassay, Cannabinoids

    FDA Pre-Market Approval
    FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Fluorescence Polarization Immunoassay For Cyclosporine

    FDA Pre-Market Approval
    FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·TLiIQ QCette

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Cyclosporine

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS INTEGRA 400 PLUS CYCLOSPORINE