PTS Detect® Cotinine System 3061

GUDID 00381933061017

Cotinine, the major metabolite of nicotine, indicates exposure to tobacco and other nicotine-containing products. Cotinine has a longer half-life than nicotine, which allows for a more accurate assessment of smoking or exposure status and better monitoring of progress in smoking cessation programs.1 Because of its longer half-life and relative ease of detection, cotinine is the choice metabolite to assess exposure to nicotine. The amount of cotinine present in the blood is proportional to the amount and recency of nicotine exposure. The PTS Detect cotinine system provides measurement of cotinine in capillary (fingerstick) or venous whole blood.

POLYMER TECHNOLOGY SYSTEMS, INC.

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00381933061017
NIH Device Record Key46bf859e-f067-4c4c-9f6d-e5438c4e8d44
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTS Detect® Cotinine System
Version Model Number3061
Catalog Number3061
Company DUNS835772872
Company NamePOLYMER TECHNOLOGY SYSTEMS, INC.
Device Count20
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Leave all components in their sealed pouches until use.
Special Storage Condition, SpecifyBetween 0 and 0 *If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, SpecifyBetween 0 and 0 *If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, SpecifyBetween 0 and 0 *Store analyzer in protective pouch when not in use.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 82 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100381933061017 [Primary]
GS110381933061014 [Unit of Use]

FDA Product Code

MRSTest system, nicotine, cotinine, metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-08
Device Publish Date2018-10-08

Devices Manufactured by POLYMER TECHNOLOGY SYSTEMS, INC.

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Trademark Results [PTS Detect]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PTS DETECT
PTS DETECT
86760806 4968130 Live/Registered
Polymer Technology Systems, Inc.
2015-09-18

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