BEUDAMED
    Product Code: JRZ FDA class 1 21 CFR 866.2350

    Media, Culture, Amino Acid Assay

    Microbiology

    The Media, Culture, Amino Acid Assay is a microbiology diagnostic culture medium specially formulated to support the microbiological assay of amino acids in biological specimens using auxotrophic microorganisms whose growth is proportional to the concentration of a specific amino acid, used in nutritional and metabolic assessments. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRZ and is regulated under 21 CFR 866.2350, within the Microbiology medical specialty.

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

    Product Code
    JRZ
    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
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    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.