Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Urea IVD, reagent FDA UDI
- Device Name
- BUN / UREA Reagent FDA UDI
- Model / Reference
- SA2024 FDA UDI
- Description
- BUN / UREA Reagent FDA UDI
Identifiers
- Catalog Number
- SA2024 FDA UDI
- Primary DI / UDI-DI
- 00857969006266 FDA UDI
- FDA Product Code
- CDN 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
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, reagent
Ace by Alfa Wassermann, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- UREA — Randox Laboratories, Ltd. · Class II
- ARCHITECT — Abbott · Class II
- ARCHITECT — Abbott · 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
- Alfa Wassermann, Inc.
Sources (1)
- FDA UDI 1a08a83e-d739-46cf-9572-2ad3de5c5cb6 35 fields · synced Jun 8, 2026