Dimension® Flex® Reagent Cartridge TU
Thyronine Uptake Flex® reagent cartridge, 160 tests
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | KHQ |
| Device type | Radioassay, Triiodothyronine Uptake |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1715 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K862359 |
| Record published | 2016-09-24 |
| Record revised | 2021-12-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10444912 | 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Laboratories | 2 |
| Atellica IM Tup | Siemens Healthcare Diagnostics Inc | 2 |
| Advia Centaur® Tup | Siemens Healthcare Diagnostics Inc | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| T3-Uptake Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| Elecsys T-Uptake | Roche Diagnostics Gmbh | 1 |
| T3 Uptake 125I RIA 200 Tube Kit | Mp Biomedicals, LLC | 1 |
| Elecsys Tuptake Assay | Roche Diagnostics Gmbh | 1 |
| ST AIA-Pack T-U | Tosoh Corp. | 1 |
| T3 Uptake 125I RIA Kit | Mp Biomedicals, LLC | 1 |
| iFlash-FT3 | Shenzhen Yhlo Biotech Co., Ltd. | 1 |
| T3 Uptake AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
Showing 12 of 23. All products under Radioassay, Triiodothyronine Uptake
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 | 2017-06-29 | Class II | Device Design | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. | 10,056 | 2020-04-23 |
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.