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…
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.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for pts panels® HDL Cholesterol Controls | Listed by | Polymer Technology Systems, United States |
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K022401 |
| Record published | 2018-09-18 |
| Record revised | 2023-01-23 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Storage | Special storage condition: Do not freeze.; Special storage condition: Use care not to contaminate dropper tip.; Special storage condition: Product is ready to use and is clear.; Special storage condition: Recap after using.; Special storage condition: Opened product is stable for at least ten months at room temperature.; Special storage condition: Do not use beyond the expiration date on the vial. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.