Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    DEN240045
    Device Name
    Teal Wand
    Manufacturer
    Teal Health, Inc.
    Date Cleared
    2025-05-09

    (255 days)

    Product Code
    SEP
    Regulation Number
    866.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    Teal Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Teal Wand is a device for the self-collection of vaginal specimens for the purpose of collecting and transporting specimens for use in an FDA approved HPV molecular assay with which the collection device has been validated. The Teal Wand can be used at-home or in any private setting. Specimens can be collected, stored, and shipped dry in an empty vial.
    Device Description
    The Teal Wand is a single patient use device intended for a person to self-collect vaginal specimens. The device consists of a plastic casing containing a swab-like projection with a foam sponge that is designed to collect the vaginal specimen. Also included are: an empty polypropylene specimen vial with a label for patient name, date of birth, and collection date, nitrile gloves, pen, product information including Instructions for Use, rigid safety bag, and return mailer. The self-collected specimen is then transported dry to a laboratory for processing and subsequent downstream high-risk HPV molecular testing as per the assay manufacturer's instructions.
    Ask a Question

    Page 1 of 1