Lipase
For the in vitro quantitative kinetic determination of Pancreatic Lipase in serum.
2manufacturers in China registered for this device type
1catalogue number
1recall
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 | Horiba Instruments Incorporated, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K897150 |
| Record published | 2016-08-31 |
| Record revised | 2025-10-02 (version 5) |
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 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-L7503-40 | 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 |
| 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 |
Showing 12 of 28. All products under Lipase-Esterase, Enzymatic, Photometric, Lipase
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Genzyme Corporation | 510(k) number | 2008-04-14 | Not classified | Nonconforming Material/Component | Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits. | 3,443 | 2008-09-16 |
| Genzyme Corporation | 510(k) number | 2008-04-14 | Not classified | Nonconforming Material/Component | Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits. | 3,443 | 2008-09-16 |
| Genzyme Corporation | 510(k) number | 2008-04-14 | Not classified | Nonconforming Material/Component | Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits. | 3,443 | 2008-09-16 |
| Genzyme Corporation | 510(k) number | 2008-04-14 | Not classified | Nonconforming Material/Component | Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits. | 3,443 | 2008-09-16 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-10-30 | Class II | Device Design | Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal b | 1539 Chemistry Analyzers | 2020-06-16 |
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.