LDL
In Vitro device for the quantitative determination of LDL-Cholesterol in serum and plasma.
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | MRR |
| Device type | System, Test, Low Density, Lipoprotein |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K982529 |
| Record published | 2018-12-24 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| 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 |
|---|---|---|
| CH3841 | 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 |
| Pointe autoLDL Cholesterol Reagent | Horiba Instruments Incorporated | 2 |
| 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 |
Showing 12 of 26. All products under System, Test, Low Density, Lipoprotein
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161691 | 2017-03-20 |
| K982529 | 1998-09-11 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2023-01-27 | Class II | Under Investigation by firm | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results | 8420 units |
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.