Identity
- Trade Name
- Synermed® FDA UDI
- Generic Name
- Urea IVD, reagent FDA UDI
- Device Name
- Urea Nitrogen (BUN) Coenzyme Reagent 6 X 500 mL FDA UDI
- Model / Reference
- UV191-L FDA UDI
- Description
- Urea Nitrogen (BUN) Coenzyme Reagent 6 X 500 mL FDA UDI
Identifiers
- Catalog Number
- UV191-L FDA UDI
- Primary DI / UDI-DI
- 05060500091781 FDA UDI
- 510(k) Number
- K911248 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
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, reagent
Synermed® by Infrared Laboratory Systems Llc — 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
K911248 also covers:
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
- Synermed® — INFRARED LABORATORY SYSTEMS LLC
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
- Infrared Laboratory Systems Llc
Sources (1)
- FDA UDI 25b7d95a-3387-4452-95d5-ce3990d0718d 37 fields · synced May 30, 2026