Dimension® Flex® Reagent Cartridge Malb
Microalbumin Flex® reagent cartridge, 80 tests
2manufacturers in China registered for this device type
1catalogue number
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 | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K033525 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10444977 | 4 | 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
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.