Identity
- Trade Name
- Urea Nitrogen (BUN) Test FDA UDI
- Generic Name
- Urea IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- For the Quantitative Colorimetric Determination of Urea Nitrogen in Serum, Plasma or Urine. FDA UDI
- Model / Reference
- 0580-250 FDA UDI
- Description
- For the Quantitative Colorimetric Determination of Urea Nitrogen in Serum, Plasma or Urine. FDA UDI
Identifiers
- Catalog Number
- 0580-250 FDA UDI
- Primary DI / UDI-DI
- 00657498001097 FDA UDI
- FDA Product Code
- CDW FDA UDI
- GMDN Term
- Urea IVD, kit, enzyme spectrophotometry 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, kit, enzyme spectrophotometry
Urea Nitrogen (BUN) Test by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, kit, enzyme spectrophotometry.
- Pointe Scientific, Inc. BUN — POINTE SCIENTIFIC, INC. · Class II
- Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
- Dimension® Flex® reagent cartridge BUN — Siemens Healthcare Diagnostics · Class II
- Pointe BUN Reagent — POINTE SCIENTIFIC, INC. · Class II
- UREA UV SL — VITALSCIENTIFIC
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC. · Class II
- Yumizen C1200 Uric acid — Horiba Abx · Class I
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI e51d7787-5651-420f-9dd4-9a2f8df516ae 36 fields · synced May 30, 2026