Pointe autoLDL Cholesterol Reagent
Pointe autoLDL Cholesterol Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 20ml R2. For the direct quantitative determination of low density lipoprotein cholesterol (LDL-C)…
Pointe autoLDL Cholesterol Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 20ml R2. For the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only.
Who Else Makes It
Concentrated in Shandong (1), Guangxi (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
Record
| Listed by | Horiba Instruments Incorporated, United States |
|---|---|
| FDA product code | MRR |
| Device type | System, Test, Low Density, Lipoprotein |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K981978 |
| Record published | 2021-01-30 |
| Record revised | 2025-10-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-L7574-320 | In distribution | |
| 16-L7574-400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 19 |
| Carolina Liquid Chemistries Corp.® LDL Cholesterol Direct Reagent KIT DT661 | Carolina Liquid Chemistries | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Direct LDL-Cholesterol (LDL) | Randox Laboratories Limited | 3 |
| N-geneous LDL-ST Cholesterol Reagent (R1) | Sekisui Diagnostics, LLC | 2 |
| Mercodia Oxidized LDL Elisa | Mercodia AB | 2 |
| ACE | Alfa Wassermann | 2 |
| N-geneous LDL-ST Cholesterol Reagent (R2) | Sekisui Diagnostics, LLC | 2 |
| Advia® Chemistry Direct LDL Cholesterol Reagents | Siemens Healthcare Diagnostics Inc | 1 |
| MedTest Dx, Inc. autoLDL | Medtest DX | 1 |
| Pointe Scientific, Inc. autoLDL Cholesterol | Horiba Instruments Incorporated | 1 |
| Dimension® Flex® reagent cartridge Aldl | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 26. All products under System, Test, Low Density, Lipoprotein
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.