Architect
Urine/CSF Protein
1manufacturer
2catalogue numbers in this listing
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 | Abbott Medical, United States |
|---|---|
| FDA product code | JGQ |
| Device type | Turbidimetric, Total Protein |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1635 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-18 |
| Record revised | 2020-06-22 (version 2) |
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 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7D79-32 | In distribution | |
| 7D79-22 | 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 |
| Total Protein Urine/CSF Gen.3 | Roche Diagnostics Gmbh | 1 |
| Thermo Scientific Infinity™ | Fisher Diagnostics | 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.