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Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

FDA product code QEP · 23 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3393
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-05-22 – 2026-07-08

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.

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