BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Albumin / BS200

    DI: 00817439020116 · Model: ALB600 · Medtest Dx, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Albumin / BS200
    Primary DI
    00817439020116
    Version / Model
    ALB600
    Catalog Number
    ALB600
    Company Name
    Medtest Dx, Inc.
    Labeler DUNS
    070371210
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-27
    Public Version
    4
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    53d04314-3795-41ed-9b22-ea51dbc0160c

    Device Description

    For the quantitative determination of Albumin in serum using the Mindray BS-200 analyzer. 4 x 40 ml

    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
    CIX Bromcresol Green Dye-Binding, Albumin

    GMDN Terms

    Code Name
    59071 Albumin IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00817439020116

    Customer Contacts

    Phone
    800-445-9853
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K822471 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius