← Back to catalogue
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics TC Matrix Clinical Chemistry Analyzer FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use.The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples. FDA UDI
- Model / Reference
- TC-Matrix FDA UDI
- Description
- Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use.The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, heating, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples. FDA UDI
Identifiers
- Catalog Number
- TC-Matrix FDA UDI
- Primary DI / UDI-DI
- 10673486013580 FDA UDI
- 510(k) Number
- K073370 FDA UDI
- FDA Product Code
- CGA FDA UDICKA FDA UDICIX FDA UDICDQ FDA UDIJJE FDA UDIJIX FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1030 FDA UDI862.1035 FDA UDI862.1770 FDA UDI862.2160 FDA UDI862.1150 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple clinical chemistry analyser IVD, laboratory
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry analyser IVD, laboratory.
- ZELLECHEM-PRO — STERILE SAFEQUIP & CHEMICALS LLP · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- ABX PENTRA 400 ISE — Horiba Abx · Class I
- IDS-iSYS Cuvettes — IMMUNODIAGNOSTIC SYSTEMS FRANCE · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- DYNEX DSX — DYNEX TECHNOLOGIES, INC. · Class I
- ABS800 Chemistry Analyzer — Shenzhen Mindray Bio-Medical Electronics Co. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI c61a19fb-a777-4624-a60e-8f9cd8112695 37 fields · synced May 30, 2026