Identity
- Trade Name
- BUN FDA UDI
- Generic Name
- Urea IVD, reagent FDA UDI
- Device Name
- The BUN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of urea nitrogen in serum, plasma and urine. FDA UDI
- Model / Reference
- UR2821 FDA UDI
- Description
- The BUN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of urea nitrogen in serum, plasma and urine. FDA UDI
Identifiers
- Catalog Number
- UR2821 FDA UDI
- Primary DI / UDI-DI
- 05055273206890 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
Bun by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Urea IVD, reagent.
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- Teco Diagnostics Urea Nitrogen (BUN) Reagent Set — TECO DIAGNOSTICS · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
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- ARCHITECT — Abbott · Class II
- ARCHITECT — Abbott · Class II
- ACE — Alfa Wassermann, Inc. · Class II
Cleared under the same submission
K923506 also covers:
- 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.
- 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 9934c8b4-2afd-4001-b1f0-ac5668a6b297 37 fields · synced May 30, 2026