FastPack® IP TSH Kit (30)
30 Test Ported TSH Immunoassay Kit
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
1recall
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 | Qualigen, Inc., United States |
|---|---|
| FDA product code | JLW |
| Device type | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1690 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K101390 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TSH Immunoassay | 30 | 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 |
| Maglumi 2000 TSH | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
Showing 12 of 87. All products under Radioimmunoassay, Thyroid-Stimulating Hormone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101390 | 2010-08-13 |
| K052301 | 2006-01-04 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-08-26 | Class II | Nonconforming Material/Component | Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected. | 60 |
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.