BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADAMII-CD34 Kit

    DI: 08809317540634 · Model: CD34K-050 · NanoEnTek, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ADAMII-CD34 Kit
    Primary DI
    08809317540634
    Version / Model
    CD34K-050
    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
    3
    Public Version Date
    2024-07-23
    Public Version Status
    Update
    Public Device Record Key
    69d13cc8-c8c2-4af5-a341-7bd6032f5752

    Device Description

    ADAMII-CD34 Kit provides enumeration of viable CD34+ cells, viable CD45+ cells, and calculates percentage of viable CD34+ cells out of viable CD45+ cells. ADAMII-CD34 Kit can be used for mobilized peripheral blood (MPB) collected in Na-Heparin or EDTA, haematopoietic progenitor cell – apheresis (HPC-A) collected in ACD or ACD+Heparin, fresh cord blood (FCB) collected in CPD, and thawed frozen cord blood (TFCB) collected in CPD and stored with 10% DMSO, 1% Dextran 40.

    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