FDA Product Code SEP: Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
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.
Leading manufacturers include Teal Health, Inc. and Becton, Dickinson and Company.
FDA 510(k) Cleared Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay Devices (Product Code SEP)
About Product Code SEP - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SEP since 2025, with 1 receiving FDA clearance (average review time: 163 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SEP devices are reviewed by the Microbiology panel. Browse all Microbiology devices →