SBZ

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Product code

SBZ

Device name

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Device class

Class 2

21 CFR

21 CFR 866.3986

Medical specialty

Microbiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-16.