AccuDiag ™
AccuDiag ™ T4 ELISA Kit For the quantitative determination of the Total Thyroxine (T4) concentration in human serum.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Diagnostic Automation, Inc. |
|---|---|
| FDA product code | KLI |
| Device type | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1700 |
| Record published | 2023-06-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DACD3149-18 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Ireland | 4 |
| DRI Thyroxine (T4) | Microgenics Corporation | 2 |
| Immulite® 2000 Systems TT4 Total T4 | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Alinity | Abbott Ireland | 2 |
| Immulite®/Immulite® 1000 Systems T4 Total T4 | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Total Thyroxine (T4) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| Access Total T4 | Beckman Coulter, Inc. | 1 |
| Total Thyroxine (tT4) Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| ACE | Alfa Wassermann | 1 |
| Cedia T4 Assay | Microgenics Corporation | 1 |
| AIA-Pack T4 Calibrator SET | Tosoh Corp. | 1 |
| ST AIA-Pack T4 | Tosoh Corp. | 1 |
Showing 12 of 30. All products under Enzyme Immunoassay, Non-Radiolabeled, 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.