Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
QEP · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3393
Classification
FDA Product Code
QEP
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3393
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.