BEUDAMED
    Product Code: JSB FDA class 1 21 CFR 866.2350

    Culture Media, Vitamin Assay

    Microbiology

    The Culture Media, Vitamin Assay is a microbiology diagnostic culture medium formulated for the microbiological assay of vitamins in biological specimens, using vitamin-requiring microorganisms whose growth is proportional to the vitamin concentration present, supporting nutritional assessment and diagnosis of vitamin deficiencies. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JSB and is regulated under 21 CFR 866.2350, within the Microbiology medical specialty.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    JSB
    Device Class
    FDA class 1
    Regulation Number
    866.2350
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

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

    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.