Teco Diagnostics Uritek TC-201 Urine Chemistry Test System TC-201

GUDID 10673486000511

Teco Diagnostics Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

TECO DIAGNOSTICS

Urine analyser IVD, point-of-care

• Primary Device ID: 10673486000511
• NIH Device Record Key: f858f35b-bac3-4493-868b-10bfedbda2c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics Uritek TC-201 Urine Chemistry Test System
• Version Model Number: TC-201
• Catalog Number: TC-201
• Company DUNS: 185067774
• Company Name: TECO DIAGNOSTICS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 18 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486000511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160372

FDA Product Code

• KQO: Automated Urinalysis System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-12
• Device Publish Date: 2024-06-04

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