T-4 Total Elisa
The DRG T4 Total ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of total Thyroxin (T4) in serum or plasma (EDTA, lithium heparin or citrate plasma).
5manufacturers in China registered for this device type
1catalogue number
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 | DRG Instruments Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | CDX |
| Device type | Radioimmunoassay, Total Thyroxine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1700 |
| Premarket notification | Exempt |
| Record published | 2023-08-31 |
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, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-4568 | 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 |
| Advia Centaur® T4 | Siemens Healthcare Diagnostics Inc | 2 |
| 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 |
Showing 12 of 31. All products under Radioimmunoassay, Total Thyroxine
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| DRG International, Inc. | UDI-DI | 2025-06-04 | Class III | Reprocessing Controls | An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). T | 47 units |
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.