BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RealTime

    DI: 00884999037298 · Model: 8L07-50 · ABBOTT MOLECULAR INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RealTime
    Primary DI
    00884999037298
    Version / Model
    8L07-50
    Catalog Number
    8L07-50
    Company Name
    ABBOTT MOLECULAR INC.
    Labeler DUNS
    878263359
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-10
    Public Version
    4
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    a14f4a61-eb93-4850-b7ba-5dc3f35860de

    Device Description

    Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LSL DNA-REAGENTS, NEISSERIA
    LIO DEVICE, SPECIMEN COLLECTION
    MKZ DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

    GMDN Terms

    Code Name
    50409 Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00884999037298

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K140354 000