BEUDAMED
    Product Code: NGS FDA class 2 21 CFR 866.3210

    Assay, Endotoxin Activity, Chemiluminescent

    Microbiology

    The Assay, Endotoxin Activity, Chemiluminescent (product code NGS) is an in vitro diagnostic assay that uses a chemiluminescent detection method to measure endotoxin activity in blood, used to aid in the diagnosis of gram-negative bacterial infections and sepsis risk stratification. It is classified as an FDA Class 2 device within the Microbiology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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    510(k)s
    2
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    2
    Years Active
    16

    Basic Information

    Product Code
    NGS
    Device Class
    FDA class 2
    Regulation Number
    866.3210
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K183176 Endotoxin Activity Assay (EAA)
    DEN030002 ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.