Identity
- Trade Name
- ClearChem Diagnostics Inc. Iron FDA UDI
- Generic Name
- Iron IVD, reagent FDA UDI
- Device Name
- In Vitro Diagnostics testing kit R1:3X60mL, R2:3X12mL FDA UDI
- Model / Reference
- IRN1150 FDA UDI
- Description
- In Vitro Diagnostics testing kit R1:3X60mL, R2:3X12mL FDA UDI
Identifiers
- Catalog Number
- IRN1150 FDA UDI
- Primary DI / UDI-DI
- 00852169008188 FDA UDI
- FDA Product Code
- JIY FDA UDI
- GMDN Term
- Iron IVD, 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Dimensions & Sizes
- Size
- Total Volume — 216 Milliliter FDA UDI
Category: Iron IVD, reagent
ClearChem Diagnostics Inc. Iron by Clearchem Diagnostics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Iron IVD, reagent.
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- Teco Diagnostics Iron Reagent Kit for TC Matrix — TECO DIAGNOSTICS · Class I
- Rowley Biochemical Muller's Colloidal Iron Oxide Stock Solution — Transene Company, Inc. · Class I
- ACE — Alfa Wassermann, Inc. · Class I
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
- Clearchem Diagnostics Inc.
Sources (1)
- FDA UDI 5cad99ca-4eef-4008-aab4-b20584c235fe 37 fields · synced May 30, 2026