Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Urea IVD, calibrator FDA UDI
- Device Name
- UREA NITROGEN STANDARD (1x 1L) FDA UDI
- Model / Reference
- BUNS-1L FDA UDI
- Description
- UREA NITROGEN STANDARD (1x 1L) FDA UDI
Identifiers
- Catalog Number
- BUNS-1L FDA UDI
- Primary DI / UDI-DI
- 00817274022672 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
No
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
JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, calibrator.
- POINTE SCIENTIFIC BUN Standard — 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
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI fd78bc0f-0a3a-4f5d-99e7-25083e400182 36 fields · synced Jun 8, 2026