ST AIA-Pack FT3
ST AIA-Pack FT3: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Total Triiodothyronine. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Tosoh Corp., Japan |
|---|---|
| FDA product code | CDP |
| Device type | Radioimmunoassay, Total Triiodothyronine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1710 |
| Establishment | Exporter |
| Record published | 2019-07-24 |
| Record revised | 2024-04-01 (version 3) |
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 |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| N/A | 5 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K897001 | 1990-03-09 |
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.