Cholestech LDX™
Cholestech LDX™ Lipid Profile
5manufacturers in China registered for this device type
1catalogue number
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 | Alere San Diego, Inc., United States |
|---|---|
| FDA product code | JGY |
| Device type | Colorimetric Method, Triglycerides |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1705 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K223179 |
| Record published | 2023-12-20 |
| Record revised | 2026-03-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 97989 | 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 |
| Piccolo Lipid Panel | Abaxis, Inc. | 1 |
| Lipid Panel, 15ct., CCPlus Home | Polymer Technology Systems | 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
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.