BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CMV Dextramer

    DI: 05714183000072 · Model: HLA-B*0702 / RPHERNGFTVL / PE · Immudex ApS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CMV Dextramer
    Primary DI
    05714183000072
    Version / Model
    HLA-B*0702 / RPHERNGFTVL / PE
    Catalog Number
    WH02135A PE 50
    Company Name
    Immudex ApS
    Labeler DUNS
    312388361
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-14
    Public Version
    2
    Public Version Date
    2022-12-30
    Public Version Status
    Update
    Public Device Record Key
    78aac00f-0f7d-423a-b269-2fd12ac947f8

    Device Description

    Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    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
    MVU Reagents, Specific, Analyte

    GMDN Terms

    Code Name
    57631 T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

    Identifiers

    Type ID
    Primary 05714183000072

    Customer Contacts

    Phone
    +1 703 766 4688
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    2-8°C in the dark