BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TLiIQ System

    DI: 25420045500874 · Model: TLiIQ System · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TLiIQ System
    Primary DI
    25420045500874
    Version / Model
    TLiIQ System
    Catalog Number
    01202
    Company Name
    Hologic, Inc.
    Labeler DUNS
    018925968
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-07
    Public Version
    1
    Public Version Date
    2024-08-15
    Public Version Status
    New
    Public Device Record Key
    6020f1f8-fc11-433d-8785-fce615105dc2

    Device Description

    System that detects fFN in cervicovaginal secretions.

    Device Characteristics

    Single Use
    No
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    LKV ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

    GMDN Terms

    Code Name
    57221 Fibronectin IVD, kit, enzyme immunohistochemistry

    Identifiers

    Type ID
    Primary 25420045500874

    Customer Contacts

    Phone
    +1(800)442-9892
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P920048 001
    P920048 002
    P920048 003
    P920048 005
    P920048 006
    P920048 009
    P920048 011
    P920048 013
    P920048 019
    P920048 024

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    50 – 80 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    18 – 30 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    18 – 30 Degrees Celsius