Cholestech LDX™
Cholestech LDX™ TC GLU
9manufacturers in China registered for this device type
3catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (4), 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 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Eaglenos Sciences, Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Medicalsystem Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Alere San Diego, Inc., United States |
|---|---|
| FDA product code | CHH |
| Device type | Enzymatic Esterase–Oxidase, Cholesterol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1175 |
| 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 |
|---|---|---|
| 97988 | In distribution | |
| 97986 | In distribution | |
| 97987 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fora | Fora Care Inc. | 8 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| JAS Diagnostics | Drew Scientific, Ltd. | 7 |
| Standard™ LipidoCare Lipid Test Strip – Lipid Profile | SD Biosensor, Inc. | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 4 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 4 |
| Carolina Liquid Chemistries Corp.® Cholesterol Reagent KIT BL211 | Carolina Liquid Chemistries | 4 |
| Cholesterol Gen.2 | Roche Diagnostics Gmbh | 3 |
| AU | Beckman Coulter, Inc. | 3 |
| Pointe Scientific, Inc. Cholesterol | Horiba Instruments Incorporated | 3 |
| Pointe Scientific Cholesterol (Liquid) | Horiba Instruments Incorporated | 3 |
| Teco Diagnostics Cholesterol Reagent Set | Teco Diagnostics | 3 |
Showing 12 of 77. All products under Enzymatic Esterase–Oxidase, Cholesterol
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-11-16 | Not classified | Device Design | Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability. | 22,000 meters | 2013-08-22 |
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.