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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.

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Product code
KHQ
Device class
2
Regulation
862.1715
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States11
Germany3
China2
Japan1
United Kingdom1
Switzerland1
Ireland1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer1March 22, 1978000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer1February 4, 1998000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer1February 4, 1998000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler1June 12, 1996000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1March 24, 1997000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer, Repackager or relabeler, Specification developer1March 24, 1997000api.fda.gov
Tosoh Aia, Inc.Toyama, JapanManufacturer1September 30, 1991000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Beijing Hotgen Biotech Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Specification developer0000api.fda.gov
Microgenics CorporationFremont, CA, United StatesManufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ortho-Clinical DiagnosticsPencoed Bridgend, United KingdomManufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov
Shenzhen Yhlo Biotech Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.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.