BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls

    DI: 08426950497011 · Model: 0009802112 · 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
    HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls
    Primary DI
    08426950497011
    Version / Model
    0009802112
    Catalog Number
    0009802112
    Company Name
    INSTRUMENTATION LABORATORY COMPANY
    Labeler DUNS
    557223252
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    7
    Public Version Date
    2023-10-23
    Public Version Status
    Update
    Public Device Record Key
    9b712a68-7ba6-482d-a097-2052956e37d4

    Device Description

    HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls

    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
    JJX Single (specified) analyte controls (assayed and unassayed)

    GMDN Terms

    Code Name
    46026 Anticardiolipin-B2-glycoprotein I complex antibody IVD, control

    Identifiers

    Type ID
    Primary 08426950497011

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Unopened controls are stable until the expiration date shown on the tube label when stored at 2-8°C.