BEUDAMED
    265 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·RAPID FFN FOR THE TLI SYSTEM

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID BRAF KIT

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·BD FOCALPOINT GS IMAGING SYSTEM

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)