← Back to catalogue
Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480 FDA UDI
- Generic Name
- Urea IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480 is used for the quantitative determination of urea concentration in serum or plasma on TC Matrix analyzers. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- B549-620 FDA UDI
- Description
- Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480 is used for the quantitative determination of urea concentration in serum or plasma on TC Matrix analyzers. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- B549-620 FDA UDI
- Primary DI / UDI-DI
- 10673486001235 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
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
Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480 by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, reagent.
- Piccolo Basic Metabolic Panel — ABAXIS, INC. · 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
- ACE — Alfa Wassermann, Inc. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
Cleared under the same submission
K981106 also covers:
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
- Teco Diagnostics
Sources (1)
- FDA UDI 7a2d9242-f4ea-45e9-b3ef-d8424637b9d0 37 fields · synced Jun 6, 2026