Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

SEA · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3386

Classification

FDA Product Code: SEA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3386
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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