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) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00381933061017 |
| NIH Device Record Key | 46bf859e-f067-4c4c-9f6d-e5438c4e8d44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTS Detect® Cotinine System |
| Version Model Number | 3061 |
| Catalog Number | 3061 |
| Company DUNS | 835772872 |
| Company Name | POLYMER TECHNOLOGY SYSTEMS, INC. |
| Device Count | 20 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Leave all components in their sealed pouches until use. |
| Special Storage Condition, Specify | Between 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, Specify | Between 0 and 0 *If refrigerated, ensure components are at room temperature prior to use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store analyzer in protective pouch when not in use. |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 64 Degrees Fahrenheit and 82 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381933061017 [Primary] |
| GS1 | 10381933061014 [Unit of Use] |
FDA Product Code
| MRS | Test system, nicotine, cotinine, metabolites |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2018-10-08 |
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Trademark Results [PTS Detect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PTS DETECT 86760806 4968130 Live/Registered |
Polymer Technology Systems, Inc. 2015-09-18 |
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