Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Total iron binding capacity IVD (TIBC), reagent FDA UDI
- Device Name
- Direct Total Iron-Binding Capacity (TIBC), for use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. Size: 1 x 90mL, 1 x 30mL FDA UDI
- Model / Reference
- HI717-120 FDA UDI
- Description
- Direct Total Iron-Binding Capacity (TIBC), for use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. Size: 1 x 90mL, 1 x 30mL FDA UDI
Identifiers
- Catalog Number
- HI717-120 FDA UDI
- Primary DI / UDI-DI
- 00811727012715 FDA UDI
- 510(k) Number
- K000781 FDA UDI
- FDA Product Code
- JMO FDA UDI
- GMDN Term
- Total iron binding capacity IVD (TIBC), reagent 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
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
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 IVD (TIBC), reagent
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K000781 also covers:
- Pointe Direct TIBC Reagent — 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
- Atellica CH TIBC — 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 |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 2ed99f22-5cdd-4068-ac0e-e68480c999f2 37 fields · synced May 31, 2026