BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pointe Homocysteine for BS480

    DI: 00811727015877 · Model: 14-H7575-144 · HORIBA INSTRUMENTS INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Pointe Homocysteine for BS480
    Primary DI
    00811727015877
    Version / Model
    14-H7575-144
    Catalog Number
    14-H7575-144
    Company Name
    HORIBA INSTRUMENTS INCORPORATED
    Labeler DUNS
    052845583
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-28
    Public Version
    3
    Public Version Date
    2025-10-02
    Public Version Status
    Update
    Public Device Record Key
    6b7aa796-b947-41b4-9e16-e393cfb6ab5b

    Device Description

    Pointe Homocysteine Reagent packaged for use on the BS480 Analyzer. 2x60mL, 2x12mL, w/calibrator kit. The Liquid Stable 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

    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
    LPS Urinary Homocystine (Nonquantitative) Test System

    GMDN Terms

    Code Name
    53747 Homocysteine IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00811727015877

    Customer Contacts

    Phone
    800-445-9853
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K083222 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius