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Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent Set
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent Set FDA UDI
- Generic Name
- Urea IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent Set 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
- B549-150 FDA UDI
- Description
- Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent Set 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
- B549-150 FDA UDI
- Primary DI / UDI-DI
- 10673486001228 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 Urea Nitrogen (BUN) Liquid Reagent Set by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI b13b5c15-a323-475b-8c89-5258dd28d676 37 fields · synced May 30, 2026