BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Calibration Serum Level 2

    DI: 00817439020338 · Model: CA1400 · Medtest Dx, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Calibration Serum Level 2
    Primary DI
    00817439020338
    Version / Model
    CA1400
    Catalog Number
    CA1400
    Company Name
    Medtest Dx, Inc.
    Labeler DUNS
    070371210
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-30
    Public Version
    4
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    3d19c5ea-1ee7-4e0a-8908-a0a7f445eb32

    Device Description

    For use as a calibrator in clinical chemistry assays.

    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
    JIX Calibrator, Multi-Analyte Mixture

    GMDN Terms

    Code Name
    47868 Multiple-type clinical chemistry analyte profile IVD, calibrator

    Identifiers

    Type ID
    Primary 00817439020338

    Customer Contacts

    Phone
    800-445-9853
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K955489 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius