Identity
- Trade Name
- Pointe Direct TIBC Reagent FDA UDI
- Generic Name
- Total iron binding capacity (TIBC) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Direct TIBC Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 36ml R2. For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 14-I7517-384 FDA UDI
- Description
- Direct TIBC Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 36ml R2. For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 14-I7517-384 FDA UDI
- Primary DI / UDI-DI
- 00811727015969 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
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, kit, spectrophotometry
Pointe Direct TIBC Reagent by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total iron binding capacity (TIBC) IVD, kit, spectrophotometry.
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Cleared under the same submission
K000781 also covers:
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 23dc37cd-8006-4508-87aa-207410989571 37 fields · synced May 31, 2026