Identity
- Trade Name
- Teco Diagnostics Potassium Reagent TC-Matrix FDA UDI
- Generic Name
- Potassium (K+) IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics Potassium Reagent TC-Matrix is used for the colorimetric determination of potassium in human serum and plasma on TC-Matrix analyzers. FDA UDI
- Model / Reference
- P605-510TM FDA UDI
- Description
- Teco Diagnostics Potassium Reagent TC-Matrix is used for the colorimetric determination of potassium in human serum and plasma on TC-Matrix analyzers. FDA UDI
Identifiers
- Catalog Number
- P605-510TM FDA UDI
- Primary DI / UDI-DI
- 10673486002157 FDA UDI
- 510(k) Number
- K902574 FDA UDI
- FDA Product Code
- CEJ FDA UDI
- GMDN Term
- Potassium (K+) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 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: Potassium (K+) IVD, reagent
Teco Diagnostics Potassium Reagent TC-Matrix by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K902574 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 72e3ec68-2515-415d-b909-e48afd602244 37 fields · synced Jun 6, 2026