JAS Diagnostics
LDL, (2 x 30 mL R1, 2 x 10mL R2)
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Drew Scientific, Ltd., United Kingdom |
|---|---|
| FDA product code | JHM |
| Device type | Colorimetric Method, Lipoproteins |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Record published | 2017-08-21 |
| Record revised | 2023-07-06 (version 3) |
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 |
|---|---|---|
| LDL4-30 | In distribution | |
| XL-LDL4-40 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 20 |
| Dimension® Flex® reagent cartridge Ahdl | Siemens Healthcare Diagnostics Inc | 1 |
| Dimension Vista® Flex® reagent cartridge Hdlc | Siemens Healthcare Diagnostics Inc | 1 |
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.