Syphilis Control 2130170
by Fujirebio Diagnostics, Inc.
Syphilis Control 2130170 is a Class I device made by Fujirebio Diagnostics, Inc., listed in FDA GUDID since 23 Jun 2017 (UDI-DI 00850212007065), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850212007065 | Date23 Jun 2017 | StatusListed |
Official records
- AccessGUDID record 00850212007065
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Syphilis Control
- Generic name
- Treponema pallidum total antibody IVD, control
- Model / reference
- 2130170
- Primary DI / UDI-DI
- 00850212007065
- FDA product code
- OHQ
- GMDN term
- Treponema pallidum total antibody IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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