Teco Diagnostics TC Matrix Clinical Chemistry Analyzer

Basic Information

• Brand Name: Teco Diagnostics TC Matrix Clinical Chemistry Analyzer
• Primary DI: 10673486013962
• Version / Model: TC-Matrix-480
• Catalog Number: TC-Matrix-480
• Company Name: TECO DIAGNOSTICS
• Labeler DUNS: 185067774
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-28
• Public Version: 1
• Public Version Date: 2025-06-05
• Public Version Status: New
• Public Device Record Key: ebc41a48-6f45-4b7d-8420-5efb00c63897

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	862.1030	1
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	862.1035	2
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	862.1770	2
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56676	Multiple clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10673486013962	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K073370	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity