pts panels® HDL Cholesterol Controls 722
GUDID 00381930722010
PTS PANELS® HDL Cholesterol Controls contain cholesterol. The analyte(s) in each solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with each set of controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements.
POLYMER TECHNOLOGY SYSTEMS, INC.
High-density lipoprotein (HDL) cholesterol IVD, control High-density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control High density lipoprotein (HDL) cholesterol IVD, control| Primary Device ID | 00381930722010 |
| NIH Device Record Key | 28fcfc11-ff68-43cb-96b7-93186cc88f86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | pts panels® HDL Cholesterol Controls |
| Version Model Number | 722 |
| Catalog Number | 722 |
| 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 | 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 |
| 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 |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Storage Environment Temperature | Between 35 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 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 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 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Use care not to contaminate dropper tip. |
| Special Storage Condition, Specify | Between 0 and 0 *Product is ready to use and is clear. |
| Special Storage Condition, Specify | Between 0 and 0 *Recap after using. |
| Special Storage Condition, Specify | Between 0 and 0 *Opened product is stable for at least ten months at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use beyond the expiration date on the vial. |
| 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 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381930722010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K022401
FDA Product Code
| JJY | Multi-analyte controls, all kinds (assayed) |
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 | 2018-10-19 |
| Device Publish Date | 2018-09-18 |
Devices Manufactured by POLYMER TECHNOLOGY SYSTEMS, INC.
| 10381933080015 - A1CNow Self Check, 8ct. | 2023-11-02 The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) lev |
| 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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