Total Protein Urine/CSF Gen.3
Catalogue number 08058679190, listed by Roche Diagnostics Gmbh, Germany, under Turbidimetric, Total Protein. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
2510(k) clearances naming this product code
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| 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) | K141925 |
| Record published | 2020-03-05 |
| Record revised | 2024-02-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08058679190 | 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 |
| Thermo Scientific Infinity™ | Fisher Diagnostics | 1 |
| Protein Total Protein in UrineCerebrospinal Fluid | Roche Diagnostics Gmbh | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072638 | 2007-10-19 |
| K071239 | 2007-09-14 |
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.