Tinaquant Albumin Gen2
Tina-quant Albumin Gen. 2 is an in vitro assay that measures albumin in human serum, plasma, urine and cerebrospinal fluid. It is used with compatible Roche/Hitachi cobas c systems. Albumin…
Tina-quant Albumin Gen. 2 is an in vitro assay that measures albumin in human serum, plasma, urine and cerebrospinal fluid. It is used with compatible Roche/Hitachi cobas c systems. Albumin measurements aid assessment of kidney and intestinal diseases.
Anti-albumin antibodies react with albumin in the sample to form complexes. These aggregates change the sample’s turbidity, which the analyzer measures to calculate albumin concentration. The method provides a quantitative result rather than a visual positive or negative reading.
Analyzer Workflow
Calibration and quality controls are part of the assay workflow, with recalibration after reagent lot changes and as required by control procedures. The appropriate application and sample requirements depend on whether serum, plasma, urine or cerebrospinal fluid is being tested.
Who Else Makes It
Concentrated in Jilin (1), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | DCF |
| Device type | Albumin, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K101203 |
| Record published | 2016-09-20 |
| Record revised | 2025-08-18 (version 5) |
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 |
|---|---|---|
| 5167043190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ortho | Ortho-Clinical Diagnostics, Inc. | 4 |
| JAS Diagnostics | Drew Scientific, Ltd. | 2 |
| N Antiserum to Human Albumin | Siemens Healthcare Diagnostics Products GmbH | 2 |
| AU | Beckman Coulter, Inc. | 2 |
| Albumin LiquiColor® | Stanbio Laboratory, L.P. | 1 |
| Microalbumin Assay | Sekisui Diagnostics, LLC | 1 |
| K-Assay® Microalbumin Reagent (L) | Kamiya Biomedical Company LLC | 1 |
| Human Albumin CSF Kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
| Microalbuminuria Kit (Immunoturbidimetric Method) | Medicalsystem Biotechnology Co., Ltd. | 1 |
| Yumizen C1200 Albumin U/CSF | Horiba ABX SAS | 1 |
| Microalbumin | Sekisui Diagnostics, LLC | 1 |
| Synchron | Beckman Coulter, Inc. | 1 |
Showing 12 of 35. All products under Albumin, Antigen, Antiserum, Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101203 | 2010-09-10 |
| K100853 | 2010-09-09 |
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.