Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Total iron binding capacity IVD (TIBC), reagent FDA UDI
- Device Name
- Iron Liquid Reagent (2 x 125 mL R1, 1 x 15 mL R2) FDA UDI
- Model / Reference
- IRO2-125 FDA UDI
- Description
- Iron Liquid Reagent (2 x 125 mL R1, 1 x 15 mL R2) FDA UDI
Identifiers
- Catalog Number
- IRO2-125 FDA UDI
- Primary DI / UDI-DI
- 00817274022580 FDA UDI
- 510(k) Number
- K864882 FDA UDI
- FDA Product Code
- JIY FDA UDI
- GMDN Term
- Total iron binding capacity IVD (TIBC), reagent 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 IVD (TIBC), reagent
JAS Diagnostics by Drew Scientific , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total iron binding capacity IVD (TIBC), reagent.
- Pointe Scientific, Inc. Direct TIBC — POINTE SCIENTIFIC, INC. · Class I
- ACE — Alfa Wassermann, Inc. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- Direct TIBC Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Class I
- Teco Diagnostics Iron/TIBC Reagent Set — TECO DIAGNOSTICS · Class I
- ClearChem Diagnostics Inc. TIBC-Direct — CLEARCHEM DIAGNOSTICS INC. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
Cleared under the same submission
K864882 also covers:
- 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. — 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
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 24f6c3db-ed0c-4d18-ad18-e1739c97501d 37 fields · synced May 30, 2026