BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ser-T-Fy 1, Level 1 Control

    DI: 00657498001202 · Model: G427-86 · STANBIO LABORATORY, L.P.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ser-T-Fy 1, Level 1 Control
    Primary DI
    00657498001202
    Version / Model
    G427-86
    Catalog Number
    G427-86
    Company Name
    STANBIO LABORATORY, L.P.
    Labeler DUNS
    045361136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    216ed2e5-0e4a-411d-87e8-0a435c8525b7

    Device Description

    Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    47869 Multiple-type clinical chemistry analyte profile IVD, control

    Identifiers

    Type ID
    Primary 00657498001202

    Customer Contacts

    Phone
    18005315535
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius