Identity
- Trade Name
- POINTE SCIENTIFIC BUN Standard FDA UDI
- Generic Name
- Urea IVD, calibrator FDA UDI
- Device Name
- Intended for use as an BUN (Urea Nitrogen) standard for standardization or calibration of Urease/GLDH, BUN (Urea Nitrogen) procedures. FDA UDI
- Model / Reference
- B7550-STD FDA UDI
- Description
- Intended for use as an BUN (Urea Nitrogen) standard for standardization or calibration of Urease/GLDH, BUN (Urea Nitrogen) procedures. FDA UDI
Identifiers
- Catalog Number
- B7550-STD FDA UDI
- Primary DI / UDI-DI
- 00811727010575 FDA UDI
- 510(k) Number
- K812341 FDA UDI
- FDA Product Code
- CDQ FDA UDI
- GMDN Term
- Urea 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
No
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, calibrator
POINTE SCIENTIFIC BUN Standard by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, calibrator.
- JAS Diagnostics — Drew Scientific , Ltd. · 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 |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI b4b7dee7-16d5-4f5f-a2da-cbdaa3f193c8 37 fields · synced May 30, 2026