BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    25 OH Vitamin D Total (90') ELISA

    DI: 04048474060874 · Model: EIA-6087 · DRG Instruments Gesellschaft mit beschränkter Haftung
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    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
    25 OH Vitamin D Total (90') ELISA
    Primary DI
    04048474060874
    Version / Model
    EIA-6087
    Catalog Number
    EIA-6087
    Company Name
    DRG Instruments Gesellschaft mit beschränkter Haftung
    Labeler DUNS
    317134468
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-01
    Public Version
    1
    Public Version Date
    2023-09-11
    Public Version Status
    New
    Public Device Record Key
    7a3b95a6-bd84-42f0-ba47-fbcc2de86cdb

    Device Description

    The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MRG System, Test, Vitamin D

    GMDN Terms

    Code Name
    58942 Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04048474060874

    Customer Contacts

    Phone
    973-564-7555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K123364 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius