PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a…
PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
Who Else Makes It
Concentrated in Zhejiang (2), Shandong (1), Guangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for PTS Panels® Triglycerides Test Strips | Listed by | Polymer Technology Systems, United States |
| FDA product code | JGY |
| Device type | Colorimetric Method, Triglycerides |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1705 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K000586 |
| Record published | 2016-07-22 |
| Record revised | 2023-07-31 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 30 °C; Special storage condition: Keep away from sunlight Keep dry; Storage environment temperature 68 to 86 °F |
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.