Immulite®/Immulite® 1000 Systems TBG
TBG - IMMULITE - RGT - 100 Tests
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | CEE |
| Device type | Radioimmunoassay, Thyroxine-Binding Globulin |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1685 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K950072 |
| Record published | 2016-09-24 |
| Record revised | 2025-10-16 (version 6) |
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 |
| Distribution end date | 2025-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10381643 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| N-TBG AccuBind Elisa Test System – 192 Wells | Monobind, Inc. | 1 |
| N-TBG AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| Immulite® 2000 Systems TGB TBG Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Immulite® Systems TBG Control | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Monobind AccuBind TBG Elisa Kit – 96 Wells | Monobind, Inc. | 1 |
| Monobind AccuLite TBG Clia Kit – 96 Wells | Monobind, Inc. | 1 |
| Immulite® 2000 Systems TU Thyroid Uptake | Siemens Healthcare Diagnostics Products GmbH | 1 |
| N-TBG AccuBind Elisa Test System – 480 Wells | Monobind, Inc. | 1 |
| Immulite® 2000 Systems TBG | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Immulite®/Immulite® 1000 Systems TU Thyroid Uptake | Siemens Healthcare Diagnostics Products GmbH | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2015-04-09 | Class II | Unknown/Undetermined by firm | IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values. | 155 kits | 2017-03-22 |
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.