Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
Medical specialty
Microbiology
Device class
2
Regulation number
866.3386
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.