BEUDAMED
    Product Code: NOM FDA class 1 21 CFR 866.3040

    Antigen, Galactomannan, Aspergillus Spp.

    Microbiology

    The Aspergillus galactomannan antigen test (Platelia Aspergillus EIA) is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum, used as an aid in diagnosing invasive aspergillosis when combined with microbiological culture, histology, and radiographic findings. It is classified as FDA Class 1 under regulation 866.3040 in the Microbiology specialty, requiring general controls but not GMP exempt, with 510(k) required. Product code NOM is eligible for third-party review and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    4
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    2
    Years Active
    22

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    Basic Information

    Product Code
    NOM
    Device Class
    FDA class 1
    Regulation Number
    866.3040
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K243496 MycoMEIA Aspergillus Assay
    K093678 PLATELIA ASPERGILLUS EIA MODEL 62793
    K060641 PLATELIA ASPERGILLUS EIA, MODEL 62793
    K023857 PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794

    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.