BEUDAMED
    Product Code: OPM FDA class 2 21 CFR 866.3510

    Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

    Microbiology

    The Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 (product code OPM) is a Class 2 in vitro diagnostic device regulated under 21 CFR 866.3510 in the Microbiology specialty (MI), cleared via 510(k). It qualitatively detects IgG antibodies to Toxoplasma gondii, Rubella, CMV, and HSV-1 and HSV-2 in human serum, aiding in the assessment of a patient's serological status to these pathogens; it is not intended for screening blood or plasma donors. The device is not an implant or life-sustaining.

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

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    Basic Information

    Product Code
    OPM
    Device Class
    FDA class 2
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to Toxoplasma gondii, Rubella, CMV and HSV 1 & 2. The test is not intended for use in screening blood or plasma donors.

    510(k) Clearance History

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    Related 510(k) Clearances

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

    K Number Device Name
    K093784 ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM

    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.