SBZ — Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users Class II
FDA product code SBZ covers "Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users", a Class II medical device regulated under 21 CFR 866.3986. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SBZ
- Device Class
- Class II
- Regulation Number
- 866.3986
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230090 | nowdiagnostics | First To Know Syphilis Test | August 16, 2024 |