Identity
- Trade Name
- IDG/Sanzay FDA UDI
- Generic Name
- Urea IVD, reagent FDA UDI
- Device Name
- Urea nitrogen (BUN) liquid reagent is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in human serum used in routine examination and monitoring of therapy and relapses. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Urea nitrogen (BUN) liquid reagent is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in human serum used in routine examination and monitoring of therapy and relapses. FDA UDI
Identifiers
- Catalog Number
- C095 FDA UDI
- Primary DI / UDI-DI
- 00850053916069 FDA UDI
- 510(k) Number
- K981106 FDA UDI
- FDA Product Code
- CDQ 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 100 Milliliter FDA UDITotal Volume — 120 Milliliter FDA UDITotal Volume — 1 Liter FDA UDITotal Volume — 240 Milliliter FDA UDITotal Volume — 250 Milliliter FDA UDITotal Volume — 500 Milliliter FDA UDI
Category: Urea IVD, reagent
IDG/Sanzay by IDG/SANZAY Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, reagent.
- Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) — TECO DIAGNOSTICS · Class II
- Piccolo Basic Metabolic Panel — ABAXIS, INC. · Class II
- Teco Diagnostics Urea Nitrogen (BUN) Reagent Set — TECO DIAGNOSTICS · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
- UREA — Randox Laboratories, Ltd. · Class II
- ARCHITECT — Abbott · Class II
- ARCHITECT — Abbott · Class II
Cleared under the same submission
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
- IDG/SANZAY Corporation
Sources (1)
- FDA UDI 140a4e68-9bb6-488f-a2a2-138e3a814a24 37 fields · synced Jun 8, 2026