AIA-Pack T4 Calibrator SET
AIA-Pack T4 Calibrator SET: 1 catalogue number listed by Tosoh Corp., Japan, under Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Tosoh Corp., Japan |
|---|---|
| FDA product code | KLI |
| Device type | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1700 |
| Establishment | Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-04-01 (version 4) |
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 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K896982 | 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.