BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CRP Reagent Kit

    DI: 00386100002244 · Model: 10228-4 · MEDICA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CRP Reagent Kit
    Primary DI
    00386100002244
    Version / Model
    10228-4
    Catalog Number
    10228-4
    Company Name
    MEDICA CORPORATION
    Labeler DUNS
    112942404
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-14
    Public Version
    3
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    95d4e323-c8ae-4095-ab76-6d24d56ac431

    Device Description

    Full Range C-Reactive Protein Reagent Kit for use with EasyRA Analyzers

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DCK C-Reactive Protein, Antigen, Antiserum, And Control

    GMDN Terms

    Code Name
    53706 C-reactive protein (CRP) IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00386100002244

    Customer Contacts

    Phone
    781-275-4892
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K130080 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius