BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RealTime

    DI: 00884999023932 · Model: 6L18-80 · 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
    00884999023932
    Version / Model
    6L18-80
    Catalog Number
    6L18-80
    Company Name
    ABBOTT MOLECULAR INC.
    Labeler DUNS
    878263359
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-01
    Public Version
    4
    Public Version Date
    2019-11-26
    Public Version Status
    Update
    Public Device Record Key
    ffc1fbef-e794-46ab-ade5-ed6de9d3fd32

    Device Description

    Abbott RealTime HIV-1 Control Kit

    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
    MZF Test, hiv detection

    GMDN Terms

    Code Name
    48466 HIV1 nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00884999023932

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    BP060002 13
    BP060002 14
    BP060002 16
    BP060002 18
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    BP060002 32
    BP060002 34
    BP060002 36
    BP060002 37
    BP060002 38
    BP060002 42
    BP060002 44
    BP060002 45
    BP060002 46
    BP060002 48
    BP060002 49
    BP060002 50
    BP060002 52
    BP060002 54
    BP060002 55
    BP060002 56
    BP060002 6
    BP060002 8
    BP060002 9

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    High: -10 Degrees Celsius