BEUDAMED
    Product Code: MIY FDA class 2 21 CFR 866.3135

    Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

    Microbiology

    The Enzyme-Linked Immunosorbent Assay for Coccidioides immitis is an in vitro diagnostic test used to detect antibodies against Coccidioides immitis, the fungal pathogen causing coccidioidomycosis (Valley fever), in patient serum to aid in diagnosis and monitoring of this respiratory fungal infection. It is classified as a Class 2 device under 21 CFR 866.3135 within the Microbiology specialty and requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

    Research product code MIY in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    MIY
    Device Class
    FDA class 2
    Regulation Number
    866.3135
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K915493 PREMIER COCCIDIOIDES

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.