BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADVIA® Chemistry CHOL_c Cholesterol Reagents, Concentrated

    DI: 00630414526744 · Model: 10335874 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

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    Basic Information

    Brand Name
    ADVIA® Chemistry CHOL_c Cholesterol Reagents, Concentrated
    Primary DI
    00630414526744
    Version / Model
    10335874
    Catalog Number
    4993681
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2020-09-24
    Public Version
    3
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    56ef0dfc-66b7-40ea-9005-3caafde80bfb

    Device Description

    Cholesterol - ADVIA Chem. - Conc. RGT - 4x2100/4x1340 tests

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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 00630414526744
    Unit of Use 00630414003719

    Customer Contacts

    Phone
    +1(877)229-3711
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K923504 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Do not freeze
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius