# Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
> **Product code: SBZ** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3986
## Classification
- **FDA Product Code:** SBZ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3986
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SBZ)
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