BEUDAMED
    Product Code: DAY FDA class 2 21 CFR 866.5240

    Complement C5, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting and quantifying complement C5, the fifth component of the complement system whose cleavage generates C5a (a potent anaphylatoxin) and C5b (which initiates the terminal complement complex). The kit includes antigen, antiserum, and control components for clinical immunology testing. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAY, regulated under 21 CFR 866.5240, within the Immunology specialty.

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    510(k)s
    3
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    3
    Years Active
    18

    Basic Information

    Product Code
    DAY
    Device Class
    FDA class 2
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Review Panel
    IM
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K942326 HUMAN C5 RID KITS
    K950102 HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
    K772075 RADIAL IMMUNODIFFUSION KIT-COMPLEMENT

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.