ChekMate™ Strips 860
GUDID 00381930860019
ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms.
POLYMER TECHNOLOGY SYSTEMS, INC.
Glucose/ketone/lipid profile IVD, calibrator| Primary Device ID | 00381930860019 |
| NIH Device Record Key | a6e7d522-4721-4187-96e5-a5c878e0ba94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ChekMate™ Strips |
| Version Model Number | 860 |
| Catalog Number | 860 |
| Company DUNS | 835772872 |
| Company Name | POLYMER TECHNOLOGY SYSTEMS, INC. |
| Device Count | 2 |
| 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 | false |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *The strips should always be stored in the original container when not in use to protect from light and from accidental scratching. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose strips to high humidity, extreme heat, cold, dust or dirt. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 68 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381930860019 [Primary] |
| GS1 | 10381930860016 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151530
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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| 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 [ChekMate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHEKMATE 98460736 not registered Live/Pending |
ABBAS, QAISAR 2024-03-21 |
 CHEKMATE 90630043 not registered Live/Pending |
Childress, Kimberly 2021-04-07 |
 CHEKMATE 87490536 not registered Dead/Abandoned |
Chekmate, LLC 2017-06-15 |
 CHEKMATE 85324188 not registered Dead/Abandoned |
POLYMER TECHNOLOGY SYSTEMS, INC. 2011-05-18 |
 CHEKMATE 75157213 2089237 Live/Registered |
DEVELOPMENTAL NATURAL RESOURCES, INC. 1996-08-26 |
 CHEKMATE 74731313 2076833 Dead/Cancelled |
Checkpoint Systems, Inc. 1995-09-19 |
 CHEKMATE 74597643 1954549 Dead/Cancelled |
STONE & WEBSTER ADVANCED SYSTEMS DEVELOPMENT SERVICES, INC. 1994-11-10 |
 CHEKMATE 74101978 not registered Dead/Abandoned |
Haver, Richard 1990-10-01 |
 CHEKMATE 73203151 1150287 Dead/Cancelled |
Zyvex International, Inc. 1979-02-08 |
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