BEUDAMED
    170 results · 115ms · Sources: EU EUDAMED, US FDA

    IRVINE BIOMEDICAL, INC.

    FDA registration
    CENTERPIECE S. DE R.L DE C.V (sterilization site)·1 product·🇲🇽 Mexico

    PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CREATININE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXSYM CYCLOSPORINE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FOX PLUS PTA CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    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

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM CORE 2.0 & AXSYM CORE 2.0 CONTROLS

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT ANTI-HCV

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT AXSYM HBSAG

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT Anti-HCV (LN 1L79)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT ANTI-HCV

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM CORE 2.0

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM CORE 2.0 (LN 8B88)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB, LN 1L82