Identity
- Trade Name
- Iron & Total Iron Binding Capacity (TIBC) Test FDA UDI
- Generic Name
- Total iron binding capacity (TIBC) IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the Quantitative Colorimetric Determination of Iron and Unsaturated Iron-Binding Capacity in Serum. FDA UDI
- Model / Reference
- 0370-110 FDA UDI
- Description
- For the Quantitative Colorimetric Determination of Iron and Unsaturated Iron-Binding Capacity in Serum. FDA UDI
Identifiers
- Catalog Number
- 0370-110 FDA UDI
- Primary DI / UDI-DI
- 00657498000939 FDA UDI
- FDA Product Code
- JIY FDA UDI
- GMDN Term
- Total iron binding capacity (TIBC) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1410 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
Yes
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: Total iron binding capacity (TIBC) IVD, kit, spectrophotometry
Iron & Total Iron Binding Capacity (TIBC) Test by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total iron binding capacity (TIBC) IVD, kit, spectrophotometry.
- Dimension® Flex® reagent cartridge IBCT — Siemens Healthcare Diagnostics · Class I
- Atellica CH TIBC — Siemens Healthcare Diagnostics · Class I
- TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) — Randox Laboratories, Ltd. · Class I
- ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents — Siemens Healthcare Diagnostics · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- TOTAL-IRON BINDING CAPACITY (TIBC) — Randox Laboratories, Ltd. · Class I
- TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) — Randox Laboratories, Ltd. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 5bd62e9e-6477-4cb2-8056-8d4b0e931f17 36 fields · synced May 30, 2026