Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set for TC Matrix G520-940TM

GUDID 10673486001761

Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set for TC Matrix is used for the quantitative determination of total glucose in human serum on TC Matrix analyzers.

TECO DIAGNOSTICS

Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent
Primary Device ID10673486001761
NIH Device Record Keyc19035ae-e998-4cde-a4bb-ff1bfa21e7a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeco Diagnostics Glucose (Oxidase) Liquid Reagent Set for TC Matrix
Version Model NumberG520-940TM
Catalog NumberG520-940TM
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110673486001761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-10

Devices Manufactured by TECO DIAGNOSTICS

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10673486001655 - Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set2023-11-27 Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set is intended to measure the activity of isoenzyme CK-MB in human serum.
10673486001792 - Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set2023-11-23 Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blo
10673486002300 - Teco Diagnostics Uric Acid Reagent Set2023-11-23 Teco Diagnostics Uric Acid Reagent Set is used for the quantitative determination of uric acid in serum.
10673486002317 - Teco Diagnostics Uric Acid Reagent Set2023-11-23 Teco Diagnostics Uric Acid Reagent Set is used for the quantitative determination of uric acid in serum.

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