Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System TC-Thunderbolt

GUDID 10673486000528

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.

TECO DIAGNOSTICS

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Primary Device ID10673486000528
NIH Device Record Key90843c4c-7745-49b9-84ff-98a03458e0a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeco Diagnostics TC-Thunderbolt Automated Urine Analyzer System
Version Model NumberTC-Thunderbolt
Catalog NumberTC-Thunderbolt
Company DUNS185067774
Company NameTECO DIAGNOSTICS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110673486000528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-14
Device Publish Date2024-06-06

Devices Manufactured by TECO DIAGNOSTICS

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