Identity
- Trade Name
- UREA FDA UDI
- Generic Name
- Urea IVD, reagent FDA UDI
- Device Name
- This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine. FDA UDI
- Model / Reference
- UR8334 FDA UDI
- Description
- This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine. FDA UDI
Identifiers
- Catalog Number
- UR8334 FDA UDI
- Primary DI / UDI-DI
- 05055273209600 FDA UDI
- 510(k) Number
- K923506 FDA UDI
- FDA Product Code
- CDQ FDA UDI
- GMDN Term
- Urea IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1770 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
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: Urea IVD, reagent
Urea by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, reagent.
- Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) — TECO DIAGNOSTICS · Class II
- Piccolo Basic Metabolic Panel — ABAXIS, INC. · Class II
- Teco Diagnostics Urea Nitrogen (BUN) Reagent Set — TECO DIAGNOSTICS · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
- ARCHITECT — Abbott · Class II
- ARCHITECT — Abbott · Class II
- ACE — Alfa Wassermann, Inc. · Class II
Cleared under the same submission
K923506 also covers:
- BUN — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
- UREA — Randox Laboratories, Ltd.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 280d93a6-f1c4-4cda-b72b-f9429b256cad 37 fields · synced May 29, 2026