BEUDAMED
    2,477 results · 48ms · Sources: EU EUDAMED, US FDA

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QuantiFERON-TB Gold and QuantiFERON -TB Gold Plus.

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    FDA Pre-Market Approval
    FDA Class 3 ·T-SPOT ®.TB

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & VITRO IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QuantiFERON - TB Gold Test and TB Gold Plus Test

    VOLATILES QC LEVEL 1

    FDA UDI
    UTAK LABORATORIES, INC.·B800VOLQC1V2U2PTLSA0·VOLATILES QC LEVEL 1

    VOLATILES QC LEVEL 2

    FDA UDI
    UTAK LABORATORIES, INC.·B800VOLQC2V2U2PTLSA0·VOLATILES QC LEVEL 2

    Glucose Oxidase, Glucose

    FDA Pre-Market Approval
    FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne®Liquid CDx (F1LCDx)

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT REAL TIME HBV CONTROL KIT

    Assay, Genotyping, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·Abbott RealTime HCV Genotype II Assay

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV ASSAY

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·Abbott RealTime HCV Assay

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·Carbomedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis, Carbo-Seal Valsalva Ascending Aortic Prosthe

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT REAL TIME HBV CALIBRATOR KIT

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·HERCEP TEST

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

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

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)

    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

    FDA Pre-Market Approval
    FDA Class 2 ·ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST