BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Coatest APC Resistance

    DI: 08426950060147 · Model: 82 2643 63 · INSTRUMENTATION LABORATORY COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Coatest APC Resistance
    Primary DI
    08426950060147
    Version / Model
    82 2643 63
    Catalog Number
    82 2643 63
    Company Name
    INSTRUMENTATION LABORATORY COMPANY
    Labeler DUNS
    557223252
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    7
    Public Version Date
    2024-01-01
    Public Version Status
    Update
    Public Device Record Key
    15121b9f-9632-46bf-8be2-b0ccdb3b8764
    Distribution End Date
    2023-12-29

    Device Description

    Coatest APC Resistance

    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
    GGW TEST, TIME, PARTIAL THROMBOPLASTIN

    GMDN Terms

    Code Name
    56223 Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting

    Identifiers

    Type ID
    Primary 08426950060147

    Customer Contacts

    Phone
    1-800-678-0710
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K945940 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    The sealed reagents are stable at 2-8°C until the expiry date printed on the label. Avoid contamination of the reagents by microorganisms
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius