Biobase
7 catalogue numbers from R1:20mL×4 R2:10mL×4, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Lipase-Esterase, Enzymatic, Photometric, Lipase. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Biobase Biodustry(Shandong)Co., Ltd., China |
|---|---|
| FDA product code | CHI |
| Device type | Lipase-Esterase, Enzymatic, Photometric, Lipase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1465 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R1:20mL×4 R2:10mL×4 | In distribution | |
| R1:40mL×2 R2:20mL×2 | In distribution | |
| R1:20mL×1 R2:10mL×1 | In distribution | |
| R1:40mL×2 R2:20mL×2 | In distribution | |
| R1:40mL×4 R2:20mL×4 | In distribution | |
| R1:50mL×2 R2:25mL×2 | In distribution | |
| R1:100mL×1 R2:50mL×1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lipase (LPS) | Randox Laboratories Limited | 4 |
| Carolina Liquid Chemistries Corp.® Lipase Reagent KIT ST621 | Carolina Liquid Chemistries | 4 |
| Lipase colorimetric assay | Roche Diagnostics Gmbh | 3 |
| Architect | Abbott Ireland | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Pointe Scientific, Inc. Lipase-Color | Horiba Instruments Incorporated | 2 |
| Alinity | Abbott Ireland | 2 |
| Architect | Abbott Laboratories | 1 |
| Dimension Vista® Flex® reagent cartridge Lipl | Siemens Healthcare Diagnostics Inc | 1 |
| MedTest Dx, Inc. Lipase (Colorimetric) | Medtest DX | 1 |
| Lipase NG OC Reagent Kit | Sentinel CH. SPA | 1 |
| Lipase colorimetric | Roche Diagnostics Gmbh | 1 |
Showing 12 of 28. All products under Lipase-Esterase, Enzymatic, Photometric, Lipase
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.