BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    K-ASSAY® Lp(a) Reagent (L)

    DI: 00816426020122 · Model: KAI-017 · KAMIYA BIOMEDICAL COMPANY, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    K-ASSAY® Lp(a) Reagent (L)
    Primary DI
    00816426020122
    Version / Model
    KAI-017
    Catalog Number
    KAI-017
    Company Name
    KAMIYA BIOMEDICAL COMPANY, LLC
    Labeler DUNS
    197934250
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    4
    Public Version Date
    2022-08-17
    Public Version Status
    Update
    Public Device Record Key
    e107d44d-033d-4306-9e85-bc0c21706c84
    Distribution End Date
    2022-08-16

    Device Description

    For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.

    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
    DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    53442 Lipoprotein A IVD, reagent

    Identifiers

    Type ID
    Primary 00816426020122

    Customer Contacts

    Phone
    206-575-8068
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K021660 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius