Immulite®/Immulite® 1000 Systems TSH Third Generation TSH
TSH - IMMULITE - RGT - 500 Tests
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Hebei (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
Record
| Listed by | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | CDP |
| Device type | Radioimmunoassay, Total Triiodothyronine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1710 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K940006 |
| Record published | 2016-09-24 |
| Record revised | 2025-10-16 (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 |
| Distribution end date | 2025-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10381627 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Ireland | 9 |
| Alinity | Abbott Ireland | 5 |
| Elecsys FT3 III | Roche Diagnostics Gmbh | 4 |
| Elecsys T3 | Roche Diagnostics Gmbh | 4 |
| Advia Centaur® T3 | Siemens Healthcare Diagnostics Inc | 3 |
| Free Triiodothyronine (fT3) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 3 |
| Total T3 125I RIA Kit | Mp Biomedicals, LLC | 3 |
| Atellica IM FT3 | Siemens Healthcare Diagnostics Inc | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 3 |
| Atellica IM T3 | Siemens Healthcare Diagnostics Inc | 3 |
| Advia Centaur® FT3 | Siemens Healthcare Diagnostics Inc | 3 |
| Free Triiodothyronine (fT3) Elisa | DRG International, Inc. | 3 |
Showing 12 of 78. All products under Radioimmunoassay, Total Triiodothyronine
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.