BEUDAMED
    37 results · 45ms · Sources: EU EUDAMED, US FDA

    MOL3960 Simplexa C. auris Positive Control Pack

    FDA registration
    DiaSorin Molecular LLC·1 product·🇺🇸 United States

    Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Device To Detect Microbial Colonization Directly From Clinical Specimens.

    FDA classification
    FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

    KIT COBAS 68/88 HIV-1/HIV-2 QUAL RMC IVD

    FDA registration
    ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

    KIT COBAS 68/88 HIV-1/HIV-2 QUAL RMC IVD

    FDA registration
    ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

    ID-FISH Plasmodium faliciparum and P. vivax Combo Test Kit

    FDA registration
    ID-FISH TECHNOLOGY, INC·1 product·🇺🇸 United States

    AccuDiag HIV NAT Elisa

    FDA registration
    Diagnostic Automation/ Cortez Diagnostics Inc,.·1 product·🇺🇸 United States

    BioFire® Global Fever Panel

    FDA UDI
    BIOFIRE DEFENSE, LLC·00851458005242·BioFire® Global Fever Panel - IVD reagent kit c...

    T2Dx® QCheck Negative Kit

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70885083760·Negative Control

    T2Candida® Reagent Trays

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70880016893·The T2Candida component that contains the refri...

    T2Dx® QCheck Negative Kit

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70885083763·Negative Control

    T2Bacteria® Cartridge Kit

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70890080710·The T2Bacteria Cartridge components used to loa...

    T2Candida® 1.1 Cartridge Kit

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70890078170·The T2Candida 1.1 Cartridge components used to ...

    T2Candida® QCheck Positive Kit

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70885083750·Positive APG Control, Positive TPK Control

    T2Candida® External Controls

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70885049190·IVD Positive APG, Positive TPK, Negative EDTA Kit

    T2Bacteria® Reagent Trays

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70880073423·The T2Bacteria component that contains the refr...

    T2Candida® Cartridge Kit

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70890017940·The T2Candida components used to load the patie...

    T2Bacteria® Reagent Trays

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70880080723·The T2Bacteria component that contains the refr...

    T2Bacteria® QCheck Negative Kit

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70885080743·Negative Control for T2Bacteria Panel

    T2Bacteria® QCheck Positive Kit

    FDA UDI
    T2 BIOSYSTEMS, INC.·M70885071910·Positive SK Control, Positive EPE Control