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510(k) Data Aggregation
K Number
DEN240045Device Name
Teal Wand
Manufacturer
Teal Health, Inc.
Date Cleared
2025-05-09
(255 days)
Product Code
SEP
Regulation Number
866.2920Why 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.
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