BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Axis® Homocysteine EIA

    DI: 05055845400015 · Model: FHCY100 · AXIS-SHIELD DIAGNOSTICS LIMITED
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Axis® Homocysteine EIA
    Primary DI
    05055845400015
    Version / Model
    FHCY100
    Catalog Number
    FHCY100
    Company Name
    AXIS-SHIELD DIAGNOSTICS LIMITED
    Labeler DUNS
    229062427
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-13
    Public Version
    6
    Public Version Date
    2025-05-30
    Public Version Status
    Update
    Public Device Record Key
    7b9542d0-ee61-4f74-9296-75043b177572
    Distribution End Date
    2024-07-04

    Device Description

    The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

    Device Characteristics

    Single Use
    Yes
    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)
    LPS Urinary Homocystine (Nonquantitative) Test System
    DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    53751 Homocysteine IVD, reagent

    Identifiers

    Type ID
    Primary 05055845400015

    Customer Contacts

    Phone
    +1-877-441-7440
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K980907 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius