Identity
- Trade Name
- Atellica CH TIBC FDA UDI
- Generic Name
- Total iron binding capacity (TIBC) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Total Iron Binding Capacity ( TIBC) Atellica CH - RGT 800T FDA UDI
- Model / Reference
- 11097525 FDA UDI
- Description
- Total Iron Binding Capacity ( TIBC) Atellica CH - RGT 800T FDA UDI
Identifiers
- Catalog Number
- 11097525 FDA UDI
- Primary DI / UDI-DI
- 00630414595535 FDA UDI
- 510(k) Number
- K000781 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
Atellica CH TIBC 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.
- TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) — Randox Laboratories, Ltd. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- Sirrus® Total Iron LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- 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
Cleared under the same submission
K000781 also covers:
- Pointe Direct TIBC Reagent — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Direct TIBC — POINTE SCIENTIFIC, INC.
- Pointe TIBC Reagent — POINTE SCIENTIFIC, INC.
- ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI e8c8f751-c2d8-444a-a024-90786e662986 37 fields · synced Jun 8, 2026