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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dimension Vista® Flex® reagent cartridge A2MAC

    DI: 00842768024412 · Model: 10465670 · Siemens Healthcare Diagnostics Products GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Dimension Vista® Flex® reagent cartridge A2MAC
    Primary DI
    00842768024412
    Version / Model
    10465670
    Catalog Number
    K7017
    Company Name
    Siemens Healthcare Diagnostics Products GmbH
    Labeler DUNS
    388240673
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    621670a3-753d-41f1-9e87-6caaef0947ad

    Device Description

    For the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® System

    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
    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
    DEB ALPHA-2-MACROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL

    GMDN Terms

    Code Name
    53925 Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 00842768024412
    Unit of Use 00842768019883

    Customer Contacts

    Phone
    +1(800)441-9250
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K081249 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius