System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

QYA · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3385

Classification

FDA Product Code: QYA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3385
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 system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 4

Source

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