Identity
- Trade Name
- BUN Reagent FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- For the quantitative determination of urea nitrogen in serum or plasma. FDA UDI
- Model / Reference
- BK-443350D FDA UDI
- Description
- For the quantitative determination of urea nitrogen in serum or plasma. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403011124 FDA UDI
- FDA Product Code
- CDS FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator 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
No
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: Multiple electrolyte IVD, calibrator
BUN Reagent by DIAMOND DIAGNOSTICS Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- DIAMOND DIAGNOSTICS Inc
Sources (1)
- FDA UDI a42e35af-336b-4f31-972b-26b0b8806996 33 fields · synced May 30, 2026