Identity
- Trade Name
- Dimension® Flex® reagent cartridge IBCT FDA UDI
- Generic Name
- Total iron binding capacity (TIBC) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Total Iron Binding Capacity Flex® reagent cartridge, 240 tests FDA UDI
- Model / Reference
- 10444944 FDA UDI
- Description
- Total Iron Binding Capacity Flex® reagent cartridge, 240 tests FDA UDI
Identifiers
- Catalog Number
- DF84 FDA UDI
- Primary DI / UDI-DI
- 00842768005756 FDA UDI
- 510(k) Number
- K994115 FDA UDI
- FDA Product Code
- JMO FDA UDI
- GMDN Term
- Total iron binding capacity (TIBC) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1415 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
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
No
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
Dimension® Flex® reagent cartridge IBCT by Siemens Healthcare Diagnostics — 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.
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- VITROS — Ortho-Clinical Diagnostics · Class I
- Iron & Total Iron Binding Capacity (TIBC) Test — STANBIO LABORATORY, L.P. · Class I
- TOTAL-IRON BINDING CAPACITY (TIBC) — Randox Laboratories, Ltd. · Class I
- TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) — 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 225a970d-3880-4fd1-941a-2619b02f2f8a 37 fields · synced May 30, 2026