# Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
> **Product code: SEP** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.2920
## Classification
- **FDA Product Code:** SEP
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.2920
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SEP)
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