ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol
In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL
3manufacturers in China registered for this device type
1catalogue number
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 | Clearchem Diagnostics Inc. |
|---|---|
| FDA product code | LBR |
| Device type | Ldl & Vldl Precipitation, Hdl |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Record published | 2018-05-18 |
| Record revised | 2020-05-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Refrigerated; Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 180 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LDL1230 | Total Volume 180 ml | 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.