SBZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3986
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| First To Know Syphilis Test (DEN230090) | Nowdiagnostics | 2024-08-16 |
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Every clearance here is in the API, with alerts when new ones post.