Identity
- Trade Name
- Syphilis Control FDA UDI
- Generic Name
- Treponema pallidum total antibody IVD, control FDA UDI
- Model / Reference
- 2130170 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850212007065 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Treponema pallidum total antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Treponema pallidum total antibody IVD, control
Syphilis Control by Fujirebio Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Treponema pallidum total antibody IVD, control.
- Atellica IM Syph QC — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott · Class I
- PreciControl Release Syphilis — Roche Diagnostics Corp. · Class I
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
- LIAISON® Treponema Serum Controls — Diasorin Inc.
- MAS Syphilis Positive Control — Microgenics Corporation · Class I
- VIROTROL — Bio-Rad Laboratories · Class I
- ARCHITECT — Abbott · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fujirebio Diagnostics, Inc.
Sources (1)
- FDA UDI 1a7d6d2a-aead-45f3-a7da-17a650ebfa62 35 fields · synced Jun 9, 2026