BEUDAMED
    Product Code: PGH FDA class 2 21 CFR 866.3307

    Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

    Microbiology

    The HSV-1 and HSV-2 CNS Nucleic-Acid Based Panel is an in vitro diagnostic test for the qualitative detection and differentiation of Herpes Simplex Virus types 1 and 2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of HSV central nervous system infection. It is an FDA Class 2 device regulated under 21 CFR 866.3307, requiring 510(k) clearance, within the Microbiology (MI) specialty. The product code is PGH, and it carries a life-sustaining flag given the critical nature of CNS infection diagnosis. Negative results do not exclude HSV infection and should not be the sole basis for treatment decisions.

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    510(k)s
    3
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    2
    Years Active
    12

    Basic Information

    Product Code
    PGH
    Device Class
    FDA class 2
    Regulation Number
    866.3307
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K250050 miDiagnostics HSV-1&2 CSF Test
    K141458 SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
    DEN130049 SIMPLEXA HSV 1&2 DIRECT

    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.