Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Total iron binding capacity (TIBC) IVD, calibrator FDA UDI
- Device Name
- Reagent intended for use as an Iron standard for standardization or calibration of ferrozine Iron procedures.1 x 30ml FDA UDI
- Model / Reference
- I7505-STD FDA UDI
- Description
- Reagent intended for use as an Iron standard for standardization or calibration of ferrozine Iron procedures.1 x 30ml FDA UDI
Identifiers
- Catalog Number
- I7505-STD FDA UDI
- Primary DI / UDI-DI
- 00811727011633 FDA UDI
- 510(k) Number
- K864882 FDA UDI
- FDA Product Code
- JIY FDA UDI
- GMDN Term
- Total iron binding capacity (TIBC) IVD, calibrator 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
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 (TIBC) IVD, calibrator
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total iron binding capacity (TIBC) IVD, calibrator.
- Dimension Vista® TIBC CAL — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Thermo Scientific — Fisher Diagnostics · Class II
- Dimension® IBCT Calibrator — Siemens Healthcare Diagnostics · Class II
- TIBC Calibrator Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Class II
- ACE — Alfa Wassermann, Inc. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K864882 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- Iron — POINTE SCIENTIFIC, INC.
- Pointe Iron Reagent — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Iron — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Iron (Ferrozine) Reagent — POINTE SCIENTIFIC, INC.
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 1399b9e1-9e3f-445e-92b4-3bed4e2873f3 37 fields · synced May 30, 2026