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Data / Medical devices / Radioimmunoassay, Thyroid-Stimulating Hormone / United States

FDA-registered makers of Radioimmunoassay, Thyroid-Stimulating Hormone in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Radioimmunoassay, Thyroid-Stimulating Hormone (product code JLW). 13 have a 510(k) clearance or PMA approval on file and 6 have a recall event. 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.

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Device
Radioimmunoassay, Thyroid-Stimulating Hormone
Product code
JLW
Country
United States

Makers of Radioimmunoassay, Thyroid-Stimulating Hormone in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer9February 6, 2026090api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer4April 4, 2024020api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer3April 4, 2008000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer3April 25, 2025030api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer2November 10, 2022040api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer, Manufacturer for export2April 4, 2008000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer2December 22, 2008010api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesManufacturer2August 13, 2010010api.fda.gov
Astoria-Pacific, Inc.Clackamas, OR, United StatesComplaint file establishment, Manufacturer1November 2, 2000000api.fda.gov
Cliawaived,inc.Carlsbad, CA, United StatesSpecification developer1June 2, 1999000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1October 23, 2008000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1October 23, 2008000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesManufacturer1February 6, 2026000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer0000api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer for export0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesContract manufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. 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.