Immulite® 2000 Systems TU Thyroid Uptake
T Uptake - IMMULITE - RGT - 200 Tests
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | CEE |
| Device type | Radioimmunoassay, Thyroxine-Binding Globulin |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1685 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K910677 |
| Record published | 2016-09-24 |
| Record revised | 2024-02-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10381669 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| N-TBG AccuBind Elisa Test System – 192 Wells | Monobind, Inc. | 1 |
| Immulite®/Immulite® 1000 Systems TBG | Siemens Healthcare Diagnostics Products GmbH | 1 |
| N-TBG AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| Immulite® 2000 Systems TGB TBG Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Immulite® Systems TBG Control | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Monobind AccuBind TBG Elisa Kit – 96 Wells | Monobind, Inc. | 1 |
| Monobind AccuLite TBG Clia Kit – 96 Wells | Monobind, Inc. | 1 |
| N-TBG AccuBind Elisa Test System – 480 Wells | Monobind, Inc. | 1 |
| Immulite® 2000 Systems TBG | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Immulite®/Immulite® 1000 Systems TU Thyroid Uptake | Siemens Healthcare Diagnostics Products 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.