BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Exact Diagnostics

    DI: 00812242030505 · Model: EVRC · EXACT DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Exact Diagnostics
    Primary DI
    00812242030505
    Version / Model
    EVRC
    Catalog Number
    EVRC
    Company Name
    EXACT DIAGNOSTICS, LLC
    Labeler DUNS
    079898166
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-24
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    c8abacca-21f2-4dd9-bb8f-f5ee8e1d99b5

    Device Description

    Enterovirus Run Control

    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
    Yes
    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
    OHQ Multi-Analyte Controls Unassayed

    GMDN Terms

    Code Name
    61045 Multiple-type meningitis-associated microorganism nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00812242030505

    Customer Contacts

    Phone
    8179899262
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – -20 Degrees Celsius