Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System

Basic Information

• Brand Name: Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System
• Primary DI: 10673486000498
• Version / Model: TC-720+
• Catalog Number: TC-720+
• Company Name: TECO DIAGNOSTICS
• Labeler DUNS: 185067774
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-05
• Public Version: 1
• Public Version Date: 2024-06-13
• Public Version Status: New
• Public Device Record Key: 522a4685-5cae-4728-ac52-24f7e079c374

Device Description

Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System consists of the Uritek TC-720+ Urine Analyzer and the Teco Diagnostics Urine Reagent Strips (URS-10). The Uritek TC-720+ 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 Strips (URS-10) as a system for the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	862.1645	1
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	862.1785	1
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	862.1550	1
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	862.1340	2
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	862.1435	1
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	864.6550	2
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	862.1115	1
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	862.1510	1
JRE	Refractometer For Clinical Use	Clinical Chemistry	862.2800	1
KQO	Automated Urinalysis System	Clinical Chemistry	862.2900	1
LIX	Aid, Cardiopulmonary Resuscitation	Cardiovascular	870.5210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57861	Urine analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10673486000498	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051526	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity