Lipase Color
Catalogue number 905-B, listed by Sekisui Diagnostics, LLC, United States, under Lipase-Esterase, Enzymatic, Photometric, Lipase. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Sekisui Diagnostics, LLC, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K897150 |
| Record published | 2016-09-20 |
| Record revised | 2026-06-30 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 905-B | 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 |
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.