BEUDAMED
    Product Code: NYO FDA class 2 21 CFR 866.5100

    Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

    Immunology

    The Autoantibodies, Anti-Ribonucleic Acid Polymerase (RNAP) III Antibody device (product code NYO) is a semi-quantitative ELISA-based in vitro diagnostic test for the detection of anti-RNA polymerase III antibodies in human serum, used as an aid in the diagnosis of systemic sclerosis (SSc) in conjunction with clinical and other laboratory findings. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.5100 within the Immunology specialty. Third-party 510(k) review is available for this device type.

    View on FDA
    510(k)s
    4
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    4
    Years Active
    15

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    Basic Information

    Product Code
    NYO
    Device Class
    FDA class 2
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    Definition

    The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.

    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
    K202541 EliA RNA Pol III
    K172078 ImmuLisa Enhanced RNA POL III Antibody ELISA
    K070066 QUANTA LITE RNA POL III ELISA
    K060431 ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.