Triglyceride-SL
2 catalogue numbers from 236-60, listed by Sekisui Diagnostics, LLC, United States, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Sekisui Diagnostics, LLC, United States |
|---|---|
| FDA product code | CDT |
| Device type | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1705 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K961281 |
| 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 | Per pack | Status |
|---|---|---|---|
| 236-60 | 2 | In distribution | |
| 236-99 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 20 |
| JAS Diagnostics | Drew Scientific, Ltd. | 8 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 7 |
| Synermed® | Infrared Laboratory Systems LLC | 6 |
| AU | Beckman Coulter, Inc. | 5 |
| Triglycerides | Roche Diagnostics Gmbh | 4 |
| Triglycerides (Trigs) | Randox Laboratories Limited | 4 |
| Carolina Liquid Chemistries Corp.® Triglycerides Reagent KIT DT213 | Carolina Liquid Chemistries | 4 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 3 |
| Teco Diagnostics Triglyceride – GPO Liquid Reagent Set | Teco Diagnostics | 3 |
| Triglycerides/Glycerol Blanked | Roche Diagnostics Gmbh | 2 |
| Teco Diagnostics Triglyceride -GPO Reagent Set | Teco Diagnostics | 2 |
Showing 12 of 48. All products under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
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.