BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADAM

    DI: 08809317540634 · Model: ADAMII-CD34 Kit · NanoEnTek, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ADAM
    Primary DI
    08809317540634
    Version / Model
    ADAMII-CD34 Kit
    Catalog Number
    CD34K-050
    Company Name
    NanoEnTek, Inc.
    Labeler DUNS
    687910463
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-02
    Public Version
    2
    Public Version Date
    2020-11-04
    Public Version Status
    Update
    Public Device Record Key
    69d13cc8-c8c2-4af5-a341-7bd6032f5752

    Device Description

    ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-based fluorescence cell counter. ADAMII-CD34 Kit provides the percentages of total and viable cells that are CD34+(%CD34).

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GKZ Counter, Differential Cell

    GMDN Terms

    Code Name
    56974 CD34 cell marker IVD, antibody

    Identifiers

    Type ID
    Primary 08809317540634

    Premarket Submissions

    Submission Number Supplement Number
    BK180283 0