BEUDAMED
    Product Code: LSF FDA class 1 21 CFR 866.3235

    Dna-Reagents, Epstein-Barr Virus

    Microbiology

    DNA reagents for Epstein-Barr virus (EBV) are nucleic acid-based diagnostic reagents used to detect EBV DNA in clinical specimens through molecular techniques such as PCR, used in the diagnosis of EBV-associated conditions including infectious mononucleosis and certain lymphomas. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LSF, regulated under 21 CFR 866.3235, within the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    LSF
    Device Class
    FDA class 1
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.