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, a class II device type, regulated under 21 CFR 866.3986. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SBZ
- Device name
- Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
- 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.
- Regulation
- 21 CFR 866.3986
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SBZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code SBZ| Applicant | Clearances |
|---|---|
| Nowdiagnostics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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