BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5T

    DI: 00682607690091 · Model: C131-2041 · Acon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    5

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    Basic Information

    Brand Name
    Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5T
    Primary DI
    00682607690091
    Version / Model
    C131-2041
    Catalog Number
    C131-2041
    Company Name
    Acon Laboratories, Inc.
    Labeler DUNS
    781100966
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    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
    676d0d2a-71c8-4ec8-9bdc-f97ccf28abb4

    Device Description

    Cholesterol lipid panel test device - 5T

    Device Characteristics

    Single Use
    Yes
    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
    CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
    LBR LDL & VLDL PRECIPITATION, HDL
    JGY COLORIMETRIC METHOD, TRIGLYCERIDES

    GMDN Terms

    Code Name
    53359 Total cholesterol lipid IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Package 10682607690098
    Primary 00682607690091
    Package 20682607690095
    Unit of Use 00682607003624

    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