BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RealTime

    DI: 00884999000698 · Model: 1N30-66 · ABBOTT MOLECULAR INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RealTime
    Primary DI
    00884999000698
    Version / Model
    1N30-66
    Catalog Number
    1N30-66
    Company Name
    ABBOTT MOLECULAR INC.
    Labeler DUNS
    878263359
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-12-01
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    75d943a9-f42b-4161-a0b1-45213b3e8847

    Device Description

    Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV (List Number 1N30-90)

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MZP ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

    GMDN Terms

    Code Name
    61119 DNA anti-contamination enzyme reagent IVD

    Identifiers

    Type ID
    Primary 00884999000698

    Customer Contacts

    Phone
    +1(800)553-7042
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -25 – -15 Degrees Celsius