Immulite®/Immulite® 1000 Systems RTH Rapid TSH
TSH - IMMULITE - RGT - 100 Tests
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Roche Diagnostics (Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | JLW |
| Device type | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1690 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K933212 |
| 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 |
|---|---|---|
| 10381637 | Withdrawn | |
| 10381628 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atellica IM TSH3-UL | Siemens Healthcare Diagnostics Inc | 4 |
| Elecsys TSH | Roche Diagnostics Gmbh | 4 |
| Advia Centaur® TSH3-UL | Siemens Healthcare Diagnostics Inc | 3 |
| Advia Centaur® TSH | Siemens Healthcare Diagnostics Inc | 3 |
| Atellica IM TSH3-Ultra II | Siemens Healthcare Diagnostics Inc | 3 |
| Free T3, Free T4, TSH Thyroid Panel AccuBind Vast Elisa Test System – 960 Wells | Monobind, Inc. | 3 |
| Architect | Abbott Ireland | 2 |
| Immulite 2000 Third Generation TSH | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Thyrotropin (TSH) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| AccuDiag ™ | Diagnostic Automation, Inc. | 2 |
| Immulite® 2000 Systems TSH Third Generation TSH | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Maglumi 2000 TSH | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
Showing 12 of 87. All products under Radioimmunoassay, Thyroid-Stimulating Hormone
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2013-05-10 | Class II | Device Design | A rare variant of TSH, identified in a small cluster of patients, is not detected. | 13462 | 2016-05-10 |
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.