BEUDAMED
    10,000 results · 54ms · Sources: EU EUDAMED, US FDA

    TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD MAX Check-Points CPO

    FDA UDI
    Check-Points Health B.V.·00180002781029·BD MAX Check-Points CPO contains: 24 each, Mast...

    Alethia™ Mycoplasma Direct External Control Kit

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733102103·The Alethia Mycoplasma Direct External Control ...

    Alethia™ Mycoplasma Direct

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733102189·The Alethia Mycoplasma Direct DNA amplification...

    illumigene Mycoplasma

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733101175·"The illumigene Mycoplasma DNA amplification as...

    illumigene Mycoplasma External Control Kit

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733101144·The illumigene Mycoplasma External Control Kit ...

    Vysis

    FDA UDI
    ABBOTT MOLECULAR INC.·00884999036406·Vysis D7S486/CEP 7 FISH Probe Kit

    illumigene Mycoplasma Direct External Control Kit

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733101281·The illumigene Mycoplasma Direct External Contr...

    illumigene Mycoplasma Direct

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733101274·The illumigene Mycoplasma Direct DNA amplificat...

    Bordetella Direct Test

    FDA UDI
    GREAT BASIN SCIENTIFIC, INC.·B178GBBORD100·Bordetella Direct Test Cartridge

    Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

    FDA Pre-Market Approval
    FDA Class 3 ·Vysis CLL FISH Probe Kit

    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

    FDA Pre-Market Approval
    FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·DAKOCYTOMATION HER2 FISH PHARMDX KIT

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·PathVysion HER-2 DNA Probe Kit

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    FDA Pre-Market Approval
    FDA Class 3 ·UroVysion Bladder Cancer Kit

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·HER2 CISH PHARMDX KIT

    Alinity m BKV AMP Kit

    FDA registration
    ABBOTT MOLECULAR, INC.·3 products·🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·Digene HC2 HPV DNA Test / Digene HC2 High Risk HPV DNA Test