DeviceClearance

Product code SBZ— Microbiology

First To Know Syphilis Test

Classification name
Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
Device class
Class 2
Regulation
21 CFR 866.3986
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SBZ under 21 CFR 866.3986, via openFDA

Market context for product code SBZ

FDA has cleared 1 device under product code SBZ, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SBZ

Recent clearances under product code SBZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.