CardioChek® Plus Professional Analyzer 2700
GUDID 00381932700016
The CardioChek® Plus professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.
POLYMER TECHNOLOGY SYSTEMS, INC.
Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multichannel clinical chemistry analyser IVD, point-of-care, battery-powered Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care Multiple clinical chemistry analyser IVD, point-of-care| Primary Device ID | 00381932700016 |
| NIH Device Record Key | b90ea9c6-0a79-4ff7-ae2b-2fa94ef95bda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CardioChek® Plus Professional Analyzer |
| Version Model Number | 2700 |
| Catalog Number | 2700 |
| Company DUNS | 835772872 |
| Company Name | POLYMER TECHNOLOGY SYSTEMS, INC. |
| Device Count | 1 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| 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. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| 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 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381932700016 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151545
FDA Product Code
| LBR | LDL & VLDL PRECIPITATION, HDL |
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 |
On-Brand Devices [CardioChek® Plus Professional Analyzer]
| 00381932701013 | The CardioChek® Plus professional analyzer is intended for in vitro diagnostic use to test whol |
| 00381932700016 | The CardioChek® Plus professional analyzer is intended for in vitro diagnostic use to test whol |
Trademark Results [CardioChek]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOCHEK 85939164 4455007 Live/Registered |
Polymer Technology Systems, Inc. 2013-05-22 |
 CARDIOCHEK 78621442 3085202 Live/Registered |
Polymer Technology Systems, Inc. 2005-05-02 |
 CARDIOCHEK 73201159 1141581 Dead/Cancelled |
Cardiac Pacemakers, Inc. 1979-01-24 |
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