Teco Diagnostics Uritek TC-201 Urine Chemistry Test System

FDA UDI

Class I (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name: Teco Diagnostics Uritek TC-201 Urine Chemistry Test System FDA UDI
Generic Name: Urine analyser IVD, point-of-care FDA UDI
Device Name: 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. FDA UDI
Model / Reference: TC-201 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: TC-201 FDA UDI
Primary DI / UDI-DI: 10673486000511 FDA UDI
510(k) Number: K160372 FDA UDI
FDA Product Code: KQO FDA UDI
JIL FDA UDI
JIO FDA UDI
LJX FDA UDI
JRE FDA UDI
CDM FDA UDI
CEN FDA UDI
JJB FDA UDI
JMT FDA UDI
JIR FDA UDI
JIN FDA UDI
GMDN Term: Urine analyser IVD, point-of-care FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2900 FDA UDI
862.1340 FDA UDI
864.6550 FDA UDI
864.7675 FDA UDI
862.2800 FDA UDI
862.1785 FDA UDI
862.1550 FDA UDI
862.1115 FDA UDI
862.1510 FDA UDI
862.1645 FDA UDI
862.1435 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

Yes

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HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

Yes

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Expiration Date

Yes

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Manufacturing Date

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Category: Urine analyser IVD, point-of-care

Teco Diagnostics Uritek TC-201 Urine Chemistry Test System by Teco Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Teco Diagnostics

Sources (1)

FDA UDI f858f35b-bac3-4493-868b-10bfedbda2c5 37 fields · synced May 30, 2026