PTS Panels® CHOL+HDL+GLU Test Strips (10-ct ) 2469

GUDID 00381932469012

PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol; HDL cholesterol; and glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer.

POLYMER TECHNOLOGY SYSTEMS, INC.

Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry
Primary Device ID00381932469012
NIH Device Record Keyff4f2051-e455-4d5f-965e-5e577d92252d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTS Panels® CHOL+HDL+GLU Test Strips (10-ct )
Version Model Number2469
Catalog Number2469
Company DUNS835772872
Company NamePOLYMER TECHNOLOGY SYSTEMS, INC.
Device Count10
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(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(877)870-5610
Emailcustomerservice@ptsdiagnostics.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100381932469012 [Primary]
GS110381932469019 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CHHENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-23
Device Publish Date2019-10-15

Devices Manufactured by POLYMER TECHNOLOGY SYSTEMS, INC.

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Trademark Results [PTS Panels]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PTS PANELS
PTS PANELS
78640726 3179677 Live/Registered
Polymer Technology Systems, Inc.
2005-05-31
PTS PANELS
PTS PANELS
78099027 not registered Dead/Abandoned
Polymer Technology Systems, Inc.
2001-12-18

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