Cedia T4 Assay
Catalogue number 100050, listed by Microgenics Corporation, United States, 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
6510(k) clearances naming this product code
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 | Microgenics Corporation, United States |
|---|---|
| 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, Exporter |
| Record published | 2016-09-26 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100050 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K943019 | 1994-10-20 |
| K942575 | 1994-07-28 |
| K941042 | 1994-04-26 |
| K935880 | 1994-03-03 |
| K884634 | 1988-12-09 |
| K852164 | 1985-07-22 |
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.