Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System

FDA UDI

Class I (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name: Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System FDA UDI
Generic Name: Urine analyser IVD, point-of-care FDA UDI
Device Name: 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. FDA UDI
Model / Reference: TC-720+ FDA UDI
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. FDA UDI

Identifiers

Catalog Number: TC-720+ FDA UDI
Primary DI / UDI-DI: 10673486000498 FDA UDI
510(k) Number: K051526 FDA UDI
FDA Product Code: JIR FDA UDI
CDM FDA UDI
CEN FDA UDI
JIL FDA UDI
JIN FDA UDI
JIO FDA UDI
JJB FDA UDI
JMT FDA UDI
JRE FDA UDI
KQO FDA UDI
LIX FDA UDI
GMDN Term: Urine analyser IVD, point-of-care FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1645 FDA UDI
862.1785 FDA UDI
862.1550 FDA UDI
862.1340 FDA UDI
862.1435 FDA UDI
864.6550 FDA UDI
862.1115 FDA UDI
862.1510 FDA UDI
862.2800 FDA UDI
862.2900 FDA UDI
870.5210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

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

FDA UDI

Category: Urine analyser IVD, point-of-care

Teco Diagnostics Uritek TC-720+ 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 522a4685-5cae-4728-ac52-24f7e079c374 37 fields · synced May 30, 2026