Teco Diagnostics Glucopad Blood Glucose Test Strips G852-B-002

GUDID 10673486000726

Teco Diagnostics Glucopad Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood (from fingertip, forearm, and palm) with the Glucopad Blood Glucose Meter. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.

TECO DIAGNOSTICS

Glucose IVD, reagent
Primary Device ID10673486000726
NIH Device Record Key57132297-3f5a-4cc6-90f6-6db64a262eda
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeco Diagnostics Glucopad Blood Glucose Test Strips
Version Model NumberGlucopad Blood Glucose Test Strips
Catalog NumberG852-B-002
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com
Phone8002229880
Emailhello@tecodiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110673486000726 [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 Date2024-12-27
Device Publish Date2024-12-19

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