Lipid Panel, 15ct., CCPlus Home
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood…
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test 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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
Record
| 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) | K151545 |
| Record published | 2023-06-20 |
| Record revised | 2023-07-06 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| REF 4753 | 15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 4 |
| Alere Cholestech LDX® | Alere San Diego, Inc. | 2 |
| Piccolo Lipid Panel Plus | Abaxis, Inc. | 1 |
| PTS Panels® Lipid Panel Test Strips | Polymer Technology Systems | 1 |
| AimStrip Tandem Total Triglycerides Test Strips | Germaine Laboratories, Inc. | 1 |
| PTS Panels® Lipid Panel Test Strips (10-ct) | Polymer Technology Systems | 1 |
| Cholestech LDX™ | Alere San Diego, Inc. | 1 |
| Piccolo Lipid Panel | Abaxis, Inc. | 1 |
| Mission Cholesterol Meter | Acon Laboratories, Inc. | 1 |
| PTS Panels® Triglycerides Test Strips | Polymer Technology Systems | 1 |
| CardioChek® PA Professional Analyzer, Refurbished | Polymer Technology Systems | 1 |
| Curo L5 TG test strip | Osang Healthcare Co., Ltd. | 1 |
Showing 12 of 13. All products under Colorimetric Method, Triglycerides
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K000586 | 2000-07-03 |
| K991894 | 2000-05-24 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Polymer Technology Systems | 510(k) number | 2019-06-07 | Class III | Under Investigation by firm | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 | 1,887 vials US; 2,728 vials OUS | 2020-07-08 |
| Polymer Technology Systems | 510(k) number | 2019-06-07 | Class III | Under Investigation by firm | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 | 559 vials | 2020-07-08 |
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.