Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
Medical specialty
Microbiology
Device class
2
Regulation number
866.3986
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Ineligible
Definition
Test for detection of antibodies associated with syphilis performed by lay users is an in vitro diagnostic device used for detection of antibodies in clinical specimens for use in home settings, or similar environments. The device is intended to aid in diagnosis of syphilis and intended for prescription use or over-the-counter use.