Immulite® 2000 Systems TT4 Total T4
T4 Total - IMMULITE - RGT - 200 Tests
2manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | KLI |
| Device type | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1700 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K910261 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-18 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10381685 | In distribution | |
| 10381664 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Ireland | 4 |
| DRI Thyroxine (T4) | Microgenics Corporation | 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 |
| Total T4 Thyroxine) | Roche Diagnostics Gmbh | 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.