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 microbiology device intended for use by lay users in home settings or similar environments to collect and transport vaginal specimens for testing with a validated, approved HPV molecular assay, supporting accessible cervical cancer screening. It is classified as FDA Class II (510(k) required) under regulation 866.2920 in the Microbiology specialty, with product code SEP. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SEP
- Device Class
- FDA class 2
- Regulation Number
- 866.2920
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.