SBZ · Class II · 21 CFR 866.3986

FDA Product Code SBZ: Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

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.

Leading manufacturers include Nowdiagnostics.

1
Total
0
Cleared
233d
Avg days
2024
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users Devices (Product Code SBZ)

1 devices
1–1 of 1
Not Cleared Aug 16, 2024
First To Know Syphilis Test
DEN230090
Nowdiagnostics
Microbiology · 233d

About Product Code SBZ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SBZ since 2024, with 0 receiving FDA clearance (average review time: 233 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SBZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →