Advia Centaur® T4
T4 Total - CENTAUR - RGT - 100 tests
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 Inc, United States |
|---|---|
| FDA product code | CDX |
| Device type | Radioimmunoassay, Total Thyroxine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K905532 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Store Upright, Protect from Light, Do not freeze, Resuspend. |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10309960 | In distribution | ||
| 10309961 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elecsys T4 | Roche Diagnostics Gmbh | 3 |
| Total T4 MAb 125I RIA Kit | Mp Biomedicals, LLC | 3 |
| AutoDELFIA Neonatal Thyroxine (T4) kit | Wallac OY | 2 |
| Elecsys CalSet T4 | Roche Diagnostics Gmbh | 1 |
| T4 AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| Mycoplasma hominis IgG Elisa | DRG International, Inc. | 1 |
| Atellica IM T4 DIL | Siemens Healthcare Diagnostics Inc | 1 |
| N-T4 AccuBind Elisa Test System – 960 Wells | Monobind, Inc. | 1 |
| N-T4 AccuBind Elisa Test System – 480 Wells | Monobind, Inc. | 1 |
| N-T4 AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| T4 SBS AccuLite Clia Test System – 192 Wells | Monobind, Inc. | 1 |
| iFlash-T4 | Shenzhen Yhlo Biotech Co., Ltd. | 1 |
Showing 12 of 31. All products under Radioimmunoassay, Total Thyroxine
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.