BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mission Cholesterol Control Solution

    DI: 00682607690084 · Model: C121-2011 · Acon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Mission Cholesterol Control Solution
    Primary DI
    00682607690084
    Version / Model
    C121-2011
    Catalog Number
    C121-2011
    Company Name
    Acon Laboratories, Inc.
    Labeler DUNS
    781100966
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-09
    Public Version
    1
    Public Version Date
    2026-03-17
    Public Version Status
    New
    Public Device Record Key
    89ffbae5-6368-4c33-bd74-728051e1a2a7

    Device Description

    Cholesterol control solution

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LBR LDL & VLDL PRECIPITATION, HDL
    CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
    JGY COLORIMETRIC METHOD, TRIGLYCERIDES

    GMDN Terms

    Code Name
    53359 Total cholesterol lipid IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Package 10682607690081
    Primary 00682607690084
    Package 20682607690088

    Customer Contacts

    Phone
    +1(800)838-9502 ext. 1
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K163406 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    36 – 86 Degrees Fahrenheit