Maglumi 2000 TSH
Maglumi 2000 TSH is an in vitro assay that measures thyroid-stimulating hormone in human serum using the Maglumi 2000 automated chemiluminescence immunoassay system. TSH measurement is used…
Maglumi 2000 TSH is an in vitro assay that measures thyroid-stimulating hormone in human serum using the Maglumi 2000 automated chemiluminescence immunoassay system. TSH measurement is used in the diagnosis of thyroid disorders.
The assay uses a sandwich reaction: antibodies on magnetic microbeads capture TSH, and another antibody carries an ABEI light-producing label. Magnetic separation and washing precede measurement of the resulting light signal.
Reagent Kit
The kit supplies low and high calibrators, buffer and three control levels alongside the capture particles and labeled antibody. The system is intended for prescription use, and the assay’s specified specimen is serum.
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 | Shenzhen NEW Industries Biomedical Engineering Co., Ltd., China |
|---|---|
| FDA product code | JLW |
| Device type | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1690 |
| Establishment | Manufacturer |
| 510(k) | K162698 |
| Record published | 2022-08-02 |
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 |
|---|---|---|
| 130203013M | In distribution | |
| 130603013M | In distribution |
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 |
| T3, T4, TSH Thyroid Panel AccuLite Vast AccuLite Clia Test System – 480 Wells | Monobind, Inc. | 2 |
Showing 12 of 87. All products under Radioimmunoassay, Thyroid-Stimulating Hormone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162698 | 2017-07-14 |
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.