BEUDAMED
    Product Code: MZL FDA not classified

    Kit, Test, Quality Control For Endotoxin

    Unknown

    The Quality Control Test Kit for Endotoxin is a laboratory device used to verify the performance of endotoxin detection assays, such as the Limulus Amebocyte Lysate (LAL) test, which is used to detect bacterial endotoxins in pharmaceutical products and medical devices. This product code (MZL) is currently not classified by the FDA (classification status "N") and is reviewed by the Immunology panel. The unclassified reason code 4 indicates it has not been formally classified.

    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MZL
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    IM
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Unclassified Reason

    4