Data / Medical devices / Calibrators, Drug Specific / United States

FDA-registered makers of Calibrators, Drug Specific in the United States: 20 establishments

Name: FDA-registered makers of Calibrators, Drug Specific in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

20 establishments in the United States are registered with the FDA to make Calibrators, Drug Specific (product code DLJ). 6 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device: Calibrators, Drug Specific
Product code: DLJ
Country: United States

Makers of Calibrators, Drug Specific in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Microgenics Corporation	Fremont, CA, United States	Contract manufacturer, Manufacturer, Manufacturer for export	6	August 27, 2001	2	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Newark, DE, United States	Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer	4	September 14, 2006	0	api.fda.gov
Beckman Coulter, Inc.	Brea, CA, United States	Specification developer	2	November 26, 1999	0	api.fda.gov
Lin-Zhi International, Inc.	Santa Clara, CA, United States	Manufacturer	2	December 16, 2002	1	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	2	March 18, 1992	0	api.fda.gov
Hemagen Diagnostics, Inc.	Baltimore, MD, United States	Manufacturer	1	November 16, 1988	0	api.fda.gov
Abbott Laboratories	Abbott Park, IL, United States	Specification developer	0		1	api.fda.gov
Ark Diagnostics Inc	Fremont, CA, United States	Manufacturer	0		0	api.fda.gov
Alere San Diego, Inc.	Pomona, CA, United States	Manufacturer	0		0	api.fda.gov
Beckman Coulter, Inc.	Carlsbad, CA, United States	Contract manufacturer	0		0	api.fda.gov
Fisher Diagnostics	Middletown, VA, United States	Contract manufacturer	0		0	api.fda.gov
Fujirebio Diagnostics, Inc.	Malvern, PA, United States	Contract manufacturer	0		0	api.fda.gov
Fujirebio Diagnostics, Inc.	Seguin, TX, United States	Contract manufacturer	0		0	api.fda.gov
Instrumentation Laboratory Co.	Orangeburg, NY, United States	Manufacturer, Manufacturer for export	0		0	api.fda.gov
INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, United States	Manufacturer for export, Repackager or relabeler	0		0	api.fda.gov
Medica Corp.	Bedford, MA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Saladax Biomedical, Inc.	Bethlehem, PA, United States	Manufacturer, Manufacturer for export	0		0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	E Walpole, MA, United States	Manufacturer	0		0	api.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.