PTS Panels® Chol+Glu Test Strips 1765

GUDID 00381931765016

PTS Panels CHOL+GLU test strips are in vitro diagnostic devices used to monitor total 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 ID00381931765016
NIH Device Record Keyc8079779-9dd4-4a8a-bcd1-fbf1170bf853
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTS Panels® Chol+Glu Test Strips
Version Model Number1765
Catalog Number1765
Company DUNS835772872
Company NamePOLYMER TECHNOLOGY SYSTEMS, INC.
Device Count25
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(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 dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep dry
Storage Environment TemperatureBetween 20 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100381931765016 [Primary]
GS110381931765013 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-15

Devices Manufactured by POLYMER TECHNOLOGY SYSTEMS, INC.

10381933080015 - A1CNow Self Check, 8ct.2023-11-02 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev
10021292015029 - TRUE+ A1CNow Self Check2023-08-07 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev
10381932488010 - Assy Vial, eGLU, 13 ct.2023-08-07 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who
10381934753017 - Lipid Panel, 15ct., CCPlus Home2023-06-28 CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL
10381934755011 - eGLU, 15ct., CCPlus Home2023-06-28 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who
10381934752010 - Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)2023-06-09 CardioChek Plus Lipid + eGLU Smart Bundle™ Self-Test test strips are in vitro diagnostic devices used to measure total cholest
10381934747016 - Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home2023-04-03 CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL
10381934748013 - Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus Home2023-04-03 The CardioChek Plus Home eGLU™ glucose test strips are in vitro diagnostic devices used to measure glucose levels in human who

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.