BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADVIA® Chemistry GLUO_c Glucose Oxidase Reagents, Concentrated

    DI: 00630414526720 · Model: 10335872 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    ADVIA® Chemistry GLUO_c Glucose Oxidase Reagents, Concentrated
    Primary DI
    00630414526720
    Version / Model
    10335872
    Catalog Number
    4993223
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    6
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    ae336083-70fc-475c-8dae-d54fc327126e

    Device Description

    Glucose - ADVIA Chem. - Conc. RGT - 8480/5200 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
    CGA GLUCOSE OXIDASE, GLUCOSE

    GMDN Terms

    Code Name
    53301 Glucose IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00630414526720
    Unit of Use 00630414003702

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K042015 000

    Storage Conditions

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