BEUDAMED
    3,046 results · 31ms · Sources: EU EUDAMED, US FDA

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB, Alinity i Anti-HBs

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

    FDA Pre-Market Approval
    FDA Class 3 ·Oncomine Dx Target Test

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/Confirmatory

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·BARD E-LUMINEXX VASCULAR STENT

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BARD FLAIR ENDOVASCULAR STENT GRAFT

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEMS

    Device, Removal, Pacemaker Electrode, Percutaneous

    FDA Pre-Market Approval
    FDA Class 3 ·SPECTRANTICS SLS II LASER SHEATH

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

    FDA Pre-Market Approval
    FDA Class 3 ·Praxis Extended RAS Panel

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·Bond Oracle HER2 IHC System

    QBC Venous Blood Tube, 100 Test Kit

    Device
    EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·On the market·32 countries

    QBC Capillary Blood Tube, 100 Test Kit

    Device
    EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·On the market·32 countries

    QBC Capillary Blood Tube, 1000 Test Kit

    Device
    EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·On the market·32 countries

    QBC Venous Blood Tube, 1000 Test Kit

    Device
    EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·On the market·32 countries

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HPV Test

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·RAPTORAIL PTCA DILATATION CATHETER (RX)

    QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

    FDA 510(k)
    FDA Class 2 ·Hematology

    NICOTINE PLUS LEVEL 2

    FDA UDI
    UTAK LABORATORIES, INC.·B800NICO2FQCLC0·NICOTINE PLUS LEVEL 2

    DRUGS OF ABUSE SCREEN POSITIVE

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAUPOSFQCVU0·DRUGS OF ABUSE SCREEN POSITIVE

    DRUGS OF ABUSE SCREEN NEGATIVE

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAUNEGFQCVU0·DRUGS OF ABUSE SCREEN NEGATIVE