Lipase (LPS)
A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma
2manufacturers in China registered for this device type
4catalogue numbers in this listing
3recalls on this code
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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | CHI |
| Device type | Lipase-Esterase, Enzymatic, Photometric, Lipase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1465 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-03 |
| Record revised | 2023-07-06 (version 2) |
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 |
|---|---|---|
| LI8361 | In distribution | |
| LI3837 | In distribution | |
| LI8050 | In distribution | |
| LI7979 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 7 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Randox Laboratories Limited | UDI-DI | 2020-06-26 | Class II | Unknown/Undetermined by firm | Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches. | 2219 kits | 2020-10-19 |
Recalls
2 of these are 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 | Closed |
|---|---|---|---|---|
| 2020-06-26 | Class II | Unknown/Undetermined by firm | Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches. | 2020-10-19 |
| 2020-06-26 | Class II | Unknown/Undetermined by firm | Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches. | 2020-10-19 |
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.