BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CHOL

    DI: 05055273201284 · Model: CH3810 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CHOL
    Primary DI
    05055273201284
    Version / Model
    CH3810
    Catalog Number
    CH3810
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-24
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    e95797f7-aa01-4441-b032-7d4346db11bc

    Device Description

    For the quantitative in vitro determination of cholesterol in serum and plasma.

    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
    CHH Enzymatic Esterase--Oxidase, Cholesterol

    GMDN Terms

    Code Name
    53359 Total cholesterol lipid IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 05055273201284

    Customer Contacts

    Phone
    +442894451070
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K923504 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store protected from light and in the absence of contamination.
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius