Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Treponema pallidum antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
- Device Name
- FTA-ABS Sorbent, 5.0 mL FDA UDI
- Model / Reference
- 31-8203 FDA UDI
- Description
- FTA-ABS Sorbent, 5.0 mL FDA UDI
Identifiers
- Catalog Number
- 31-8203 FDA UDI
- Primary DI / UDI-DI
- 05391516747745 FDA UDI
- FDA Product Code
- GMW FDA UDI
- GMDN Term
- Treponema pallidum antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3830 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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 antigen IVD, kit, direct fluorescent test (DFT)
Trinity Biotech by Mardx Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Mardx Diagnostics, Inc.
Sources (1)
- FDA UDI a2ac8efd-f5d7-4da2-87bd-e46db55e17b5 36 fields · synced May 30, 2026