SEP
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2920
- Medical specialty
- Microbiology
- FDA definition
- A device for home collection and transport of vaginal specimens by lay users for HPV testing is a device intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for testing using an approved HPV molecular assay with which the device has been validated.
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| Record | Firm | Date |
|---|---|---|
| Onclarity™ Self-Collection Kit (K260184) | Becton, Dickinson and Company | 2026-04-02 |
| Teal Wand (DEN240045) | Teal Health, Inc. | 2025-05-09 |
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Every clearance here is in the API, with alerts when new ones post.