ox-LDL Elisa
2 catalogue numbers from K 7810.US, listed by Immundiagnostik, Inc., United States, under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Immundiagnostik, Inc., United States |
|---|---|
| FDA product code | LBS |
| Device type | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K 7810.US | In distribution | |
| K 7810.20.US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| JAS Diagnostics | Drew Scientific, Ltd. | 6 |
| Direct HDL-Cholesterol (HDL) | Randox Laboratories Limited | 4 |
| Synermed® | Infrared Laboratory Systems LLC | 4 |
| AU | Beckman Coulter, Inc. | 4 |
| HDL-Cholesterol Gen.4 | Roche Diagnostics Gmbh | 4 |
| Direct HDL Cholesterol LiquiColor® | Stanbio Laboratory, L.P. | 3 |
| Ultra N-geneous HDL Cholesterol Reagent | Sekisui Diagnostics, LLC | 2 |
| Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents | Siemens Healthcare Diagnostics Inc | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Alinity | Abbott Medical | 2 |
| ACE | Alfa Wassermann | 2 |
| HDL Ultra Cholesterol | Sekisui Diagnostics, LLC | 2 |
Showing 12 of 30. All products under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, 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.