Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System

FDA UDI

Class I (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name: Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System FDA UDI
Generic Name: Urine analyser IVD, laboratory FDA UDI
Device Name: Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with the TC-Thunderbolt Automated Urine Analyzer System; they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for point-of-care use. 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-Thunderbolt FDA UDI
Description: Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with the TC-Thunderbolt Automated Urine Analyzer System; they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for point-of-care use. 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-Thunderbolt FDA UDI
Primary DI / UDI-DI: 10673486000528 FDA UDI
510(k) Number: K141289 FDA UDI
FDA Product Code: JIR FDA UDI
JIL FDA UDI
JIO FDA UDI
KQO FDA UDI
LJX FDA UDI
JRE FDA UDI
CEN FDA UDI
JMT FDA UDI
JIN FDA UDI
CDM FDA UDI
JJB FDA UDI
GMDN Term: Urine analyser IVD, laboratory FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1645 FDA UDI
862.1340 FDA UDI
864.6550 FDA UDI
862.2900 FDA UDI
864.7675 FDA UDI
862.2800 FDA UDI
862.1550 FDA UDI
862.1510 FDA UDI
862.1435 FDA UDI
862.1785 FDA UDI
862.1115 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, laboratory

Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System by Teco Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K141289 also covers:

TECO DIAGNOSTICS — TECO DIAGNOSTICS

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 90843c4c-7745-49b9-84ff-98a03458e0a6 37 fields · synced Jun 1, 2026