The quanTtest red Total Protein Assay System is intended for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems. The quanTtest…
The quanTtest red Total Protein Assay System is intended for the quantitative determination of protein in cerebrospinal fluid and urine for both manual and automated systems. The quanTtest red Total Protein Assay System provides a simple method of protein quantitation using microliter samples of urine or cerebrospinal fluid. Total Protein is measured by the dye binding method using a complex of pyrogallol red and molybdenum acid (Mo+6). At low pH the dye is red and changes to blue when complexed with protein.The kit consists of reagent, controls for both CSF and urine chemistry, and four reagent standards: Level 2 (25 mg/dL), Level 3 (50 mg/dL), Level 4 (100 mg/dL), and Level 5 (200 mg/dL).
Who Else Makes It
Concentrated in Zhejiang (1), Jilin (1), Shandong (1).
Record
Regulatory record for QuanTtest Red Reagent Total Protein Assay System | Listed by | Quantimetrix Corp., United States |
| FDA product code | CEK |
| Device type | Biuret (Colorimetric), Total Protein |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1635 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K904603 |
| Record published | 2017-06-30 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature 18 to 25 °C |
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.