BEUDAMED
    Product Code: LGY FDA class 1 21 CFR 864.1850

    Trypan Blue

    Hematology

    Trypan blue is a dye used in hematology and pathology laboratories as a cell viability stain, exploiting the principle that viable cells with intact membranes exclude the dye while non-viable cells take up the blue color, enabling the discrimination of live from dead cells. The device is FDA Class 1, the lowest risk category, requiring only general controls and not requiring premarket notification. It bears product code LGY and is regulated under 21 CFR 864.1850 within the Hematology specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LGY
    Device Class
    FDA class 1
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Review Panel
    PA
    Submission Type
    4

    Device Characteristics

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

    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
    K810782 TRYPAN BLUE (0.5% IN NORMAL SALINE)

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.