FDA product code SBZ: Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
SBZ is the FDA product code for test for detection of antibodies associated with syphilis performed by lay users. It is a Class II device, regulated under 21 CFR 866.3986 and reviewed by the Microbiology panel. Devices under SBZ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users |
| Device class | Class II |
| Regulation | 21 CFR 866.3986 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for SBZ devices
openFDA lists no recalls for product code SBZ.
Frequently asked questions
What is FDA product code SBZ?
SBZ is the FDA product code for test for detection of antibodies associated with syphilis performed by lay users. It is a Class II device, regulated under 21 CFR 866.3986 and reviewed by the Microbiology panel.
What device class is SBZ?
Class II, regulation 21 CFR 866.3986. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SBZ
- Run a recall and safety report across every SBZ manufacturer
- Watch product code SBZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.