Alinity
Lipase2 Calibrator
2manufacturers in China registered for this device type
2catalogue 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 | Abbott Ireland, Ireland |
|---|---|
| FDA product code | CHI |
| Device type | Lipase-Esterase, Enzymatic, Photometric, Lipase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1465 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-24 |
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 -20 to -20 °C; Handling environment temperature up to 0 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04U0001 | In distribution | |
| 04U0020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 7 |
| 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 |
| 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.