Data / Medical devices / Radioassay, Triiodothyronine Uptake
Radioassay, Triiodothyronine Uptake (KHQ): 20 FDA-registered makers in 7 countries
20 establishments in 7 countries are registered with the FDA to make Radioassay, Triiodothyronine Uptake (product code KHQ, Class 2, 21 CFR 862.1715). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 93 510(k) clearances under this code, the latest on June 10, 1998, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- KHQ
- Device class
- 2
- Regulation
- 862.1715
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Germany | 3 |
| China | 2 |
| Japan | 1 |
| United Kingdom | 1 |
| Switzerland | 1 |
| Ireland | 1 |
Makers of Radioassay, Triiodothyronine Uptake
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 1 | March 22, 1978 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | February 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer | 1 | February 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler | 1 | June 12, 1996 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | March 24, 1997 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | March 24, 1997 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 1 | September 30, 1991 | 0 | 0 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Hotgen Biotech Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microgenics Corporation | Fremont, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 10, 1998. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.