LDL Cholesterol Reagent Set
The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the…
The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
Who Else Makes It
Concentrated in Zhejiang (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Clinical Diagnostic Solutions, Inc., United States |
|---|---|
| FDA product code | LBR |
| Device type | Ldl & Vldl Precipitation, Hdl |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2016-10-12 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R1 x 2 x 70mL, R2 x 1 x 50mL | 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 11 |
| Synermed® | Infrared Laboratory Systems LLC | 4 |
| LDL-Cholesterol Gen.3 | Roche Diagnostics Gmbh | 3 |
| L-Type HDL-C Reagent 2 | Fujifilm Wako Pure Chemical Corporation | 2 |
| Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix | Teco Diagnostics | 2 |
| N-geneous LDL Cholesterol Reagent (R1) | Sekisui Diagnostics, LLC | 2 |
| N-geneous LDL Cholesterol Reagent (R2) | Sekisui Diagnostics, LLC | 2 |
| PTS Panels® HDL Cholesterol Test Strips | Polymer Technology Systems | 2 |
| Teco Diagnostics HDL Cholesterol Reagent Set | Teco Diagnostics | 2 |
| CardioChek | Henry Schein, Inc. | 2 |
| L-Type HDL-C Reagent 1 | Fujifilm Wako Pure Chemical Corporation | 2 |
| Carolina Liquid Chemistries Corp.® CLC720 HDL RGT KIT Product No. ST616 | Carolina Liquid Chemistries | 1 |
Showing 12 of 47. All products under Ldl & Vldl Precipitation, Hdl
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.