Alinity
Alinity c Triglyceride Reagent Kit
2manufacturers in China registered for this device type
1catalogue number
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 | Abbott Medical, 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, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K953971 |
| Record published | 2018-07-11 |
| Record revised | 2023-08-18 (version 4) |
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; Handling environment temperature up to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07P7720 | 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 |
| Triglyceride-SL | Sekisui Diagnostics, LLC | 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.