BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QuanTtest Human Protein Standards Set

    DI: M0513410021 · Model: 3410-02 · QUANTIMETRIX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    QuanTtest Human Protein Standards Set
    Primary DI
    M0513410021
    Version / Model
    3410-02
    Catalog Number
    3410-02
    Company Name
    QUANTIMETRIX CORPORATION
    Labeler DUNS
    010717890
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-31
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    4ccab6f5-c3c5-4013-a601-044f77f5dc21

    Device Description

    QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay System. The standards are used to establish curves and to calibrate manual and automated methods for cerebrospinal fluid and urine total protein assays. Four protein standard concentrations are available: 25, 50, 100, and 200 mg/dl.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    CEK Biuret (Colorimetric), Total Protein

    GMDN Terms

    Code Name
    53985 Total protein IVD, kit, enzyme spectrophotometry

    Identifiers

    Type ID
    Primary M0513410021

    Customer Contacts

    Phone
    (310) 536-0006
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K853932 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius