PTS Panels® Ketones Test Strips 1718
GUDID 00381931718012
PTS Panels® Ketone Test Strips are in vitro diagnostic devices used to monitor ketone levels in human whole blood. These test strips must be used in conjunction with a CardioChek or CardioChek PA analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry| Primary Device ID | 00381931718012 |
| NIH Device Record Key | df50c36b-adf2-4b1c-82b9-f240fe1fc1d8 |
| Commercial Distribution Discontinuation | 2017-01-20 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PTS Panels® Ketones Test Strips |
| Version Model Number | 1718 |
| Catalog Number | 1718 |
| Company DUNS | 835772872 |
| Company Name | POLYMER TECHNOLOGY SYSTEMS, INC. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381931718012 [Primary] |
| GS1 | 10381931718019 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K981865
FDA Product Code
| JMK | ACID, ALPHA-KETOBUTYRIC AND NADH (U.V.), HYDROXYBUTYRIC DEHYDROGENASE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-08 |
Devices Manufactured by POLYMER TECHNOLOGY SYSTEMS, INC.
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| 10021292015029 - TRUE+ A1CNow Self Check | 2023-08-07 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 Home | 2023-06-28 CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL |
| 10381934755011 - eGLU, 15ct., CCPlus Home | 2023-06-28 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 Home | 2023-04-03 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 Home | 2023-04-03 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 78640726 3179677 Live/Registered |
Polymer Technology Systems, Inc. 2005-05-31 |
 PTS PANELS 78099027 not registered Dead/Abandoned |
Polymer Technology Systems, Inc. 2001-12-18 |
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