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 Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies Multiple lipid analyte IVD, kit, multiple technologies| Primary Device ID | 00381931765016 |
| NIH Device Record Key | c8079779-9dd4-4a8a-bcd1-fbf1170bf853 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTS Panels® Chol+Glu Test Strips |
| Version Model Number | 1765 |
| Catalog Number | 1765 |
| 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 | true |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 28 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381931765016 [Primary] |
| GS1 | 10381931765013 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162282
FDA Product Code
| CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL |
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 | 2016-07-15 |
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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