Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown