BEUDAMED
    Product Code: SCE FDA not classified

    Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    Unknown

    This product code covers in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and have not been modified following that date or not modified beyond the scope described in the LDT Final Rule preamble (89 FR 37286); these are currently marketed LDTs grandfathered under FDA's enforcement discretion policy. The device class is FDA Not Classified (N), with product code SCE, reviewed by the Clinical Chemistry panel; no regulation number or medical specialty is assigned. These tests are not implants and do not support life-sustaining functions.

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

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    Basic Information

    Product Code
    SCE
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    CH
    Submission Type
    7

    Device Characteristics

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

    Definition

    Currently marketed in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and not modified following that date or not modified beyond the scope described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).

    Unclassified Reason

    6