AIA-Pack T-U Calibrator SET
AIA-Pack T-U Calibrator SET: 1 catalogue number listed by Tosoh Corp., Japan, under Radioassay, Triiodothyronine Uptake. 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 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 | Tosoh Corp., Japan |
|---|---|
| FDA product code | KHQ |
| Device type | Radioassay, Triiodothyronine Uptake |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1715 |
| Establishment | Exporter |
| Premarket notification | Exempt |
| Record published | 2019-07-25 |
| 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 |
| Packaging | Pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | 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 |
| Dimension® Flex® reagent cartridge TU | Siemens Healthcare Diagnostics Inc | 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 |
Showing 12 of 23. All products under Radioassay, Triiodothyronine Uptake
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K913663 | 1991-09-30 |
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.