PTS Panels eGLU™ Test Strips 2728

GUDID 00381932728010

PTS Panels eGLU™ test strips are in vitro diagnostic devices used to monitor glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek® Plus analyzer.

POLYMER TECHNOLOGY SYSTEMS, INC.

Glucose/ketone/lipid profile IVD, kit, multiple technologies
Primary Device ID00381932728010
NIH Device Record Keyd038b49f-912d-48dc-ade9-3952646c8361
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTS Panels eGLU™ Test Strips
Version Model Number2728
Catalog Number2728
Company DUNS835772872
Company NamePOLYMER TECHNOLOGY SYSTEMS, INC.
Device Count15
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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-Countertrue

Customer Support Contacts

Phone+1(888)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100381932728010 [Primary]
GS110381932728017 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-22

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