Thermo Scientific Infinity™
Catalogue number TR50001, listed by Fisher Diagnostics, United States, under Turbidimetric, Total Protein. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jilin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
Record
| Listed by | Fisher Diagnostics, United States |
|---|---|
| FDA product code | JGQ |
| Device type | Turbidimetric, Total Protein |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1635 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K925794 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TR50001 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Total Protein UrineCSF Gen3 | Roche Diagnostics Gmbh | 2 |
| Alinity | Abbott Medical | 2 |
| Architect | Abbott Laboratories | 2 |
| Architect | Abbott Medical | 2 |
| Total Protein Urine/CSF Gen.3 | Roche Diagnostics Gmbh | 1 |
| Protein Total Protein in UrineCerebrospinal Fluid | Roche Diagnostics Gmbh | 1 |
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.