Data / Medical devices / Immunohistochemistry Reagents And Kits / United States

FDA-registered makers of Immunohistochemistry Reagents And Kits in the United States: 24 establishments

Name: FDA-registered makers of Immunohistochemistry Reagents And Kits in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

24 establishments in the United States are registered with the FDA to make Immunohistochemistry Reagents And Kits (product code NJT). 0 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device: Immunohistochemistry Reagents And Kits
Product code: NJT
Country: United States

Makers of Immunohistochemistry Reagents And Kits in the United States

Maker	Location	Role	Recall events	Class I	Source
Antibodies Incorporated	Davis, CA, United States	Contract manufacturer	0	0	api.fda.gov
Agilent Technologies, Inc	Santa Clara, CA, United States	Specification developer	0	0	api.fda.gov
Agilent Technologies, Inc.	Carpinteria, CA, United States	Manufacturer	1	0	api.fda.gov
Bio SB, Inc.	Santa Barbara, CA, United States	Contract manufacturer, Manufacturer, Remanufacturer	0	0	api.fda.gov
Biocare Medical, LLC	Pacheco, CA, United States	Manufacturer, Repackager or relabeler	9	0	api.fda.gov
Biogenex Laboratories Inc.	Fremont, CA, United States	Manufacturer	2	0	api.fda.gov
Biolegend, Inc.	San Diego, CA, United States	Manufacturer	0	0	api.fda.gov
Cell Marque Corp.	Saint Louis, MO, United States	Manufacturer	0	0	api.fda.gov
Cell Marque Corp.	Rocklin, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	4	0	api.fda.gov
Diagnostic Biosystems	Pleasanton, CA, United States	Manufacturer, Remanufacturer	0	0	api.fda.gov
Lumatas Biosystems, Inc	Milpitas, CA, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Life Technologies Corporation	Frederick, MD, United States	Manufacturer	0	0	api.fda.gov
Metamol Theranostics	Milford, OH, United States	Specification developer	0	0	api.fda.gov
Microgenics Corporation	Fremont, CA, United States	Contract manufacturer, Manufacturer	0	0	api.fda.gov
Newcomer Supply Inc	Waunakee, WI, United States	Specification developer	0	0	api.fda.gov
Novodiax, Inc.	Hayward, CA, United States	Manufacturer	0	0	api.fda.gov
Pathcom Systems Corporation	Dublin, CA, United States	Manufacturer	0	0	api.fda.gov
Proteintech Group Inc	Rosemont, IL, United States	Contract manufacturer	0	0	api.fda.gov
Richard-Allan Scientific LLC	Kalamazoo, MI, United States	Manufacturer	0	0	api.fda.gov
Sakura Finetek U.s.a., Inc.	Torrance, CA, United States	Complaint file establishment, Manufacturer	0	0	api.fda.gov
Scytek Laboratories, Inc.	Logan, UT, United States	Manufacturer	0	0	api.fda.gov
Ventana Medical Systems, Inc.	Tucson, AZ, United States	Manufacturer, Manufacturer for export	3	2	api.fda.gov
Wavesense, Inc.	Irvine, CA, United States	Manufacturer	0	0	api.fda.gov
Zeta Corporation	Monrovia, CA, 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.