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Data / Medical devices / Immunohistochemistry Reagents And Kits

Immunohistochemistry Reagents And Kits (NJT): 40 FDA-registered makers in 9 countries

40 establishments in 9 countries are registered with the FDA to make Immunohistochemistry Reagents And Kits (product code NJT, Class 1, 21 CFR 864.1860). 0 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 43 recall events (2 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
NJT
Device class
1
Regulation
864.1860
Medical specialty
Hematology

Makers by country

CountryMakers
United States24
China7
Australia2
India2
Denmark1
Singapore1
United Kingdom1
Taiwan1
Germany1

Makers of Immunohistochemistry Reagents And Kits

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
Antibodies IncorporatedDavis, CA, United StatesContract manufacturer0000api.fda.gov
Agilent Technologies Denmark ApSGLOSTRUP Hovedstaden, DenmarkManufacturer, Specification developer0010api.fda.gov
Agilent Technologies Singapore (International) Pte Ltd.Singapore North East, SingaporeSpecification developer0000api.fda.gov
Agilent Technologies, IncSanta Clara, CA, United StatesSpecification developer0000api.fda.gov
Agilent Technologies, Inc.Carpinteria, CA, United StatesManufacturer0010api.fda.gov
Bio SB, Inc.Santa Barbara, CA, United StatesContract manufacturer, Manufacturer, Remanufacturer0000api.fda.gov
Biocare Medical, LLCPacheco, CA, United StatesManufacturer, Repackager or relabeler0090api.fda.gov
Biogenex Laboratories Inc.Fremont, CA, United StatesManufacturer0020api.fda.gov
Biolegend, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Cell Marque Corp.Saint Louis, MO, United StatesManufacturer0000api.fda.gov
Cell Marque Corp.Rocklin, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0040api.fda.gov
Diagnostic BiosystemsPleasanton, CA, United StatesManufacturer, Remanufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaManufacturer0000api.fda.gov
Fuzhou Maixin Biotech Co., Ltd.Fuzhou City Fujian, ChinaManufacturer0000api.fda.gov
Henan Celnovte Biotechnology Co., Ltd.zhengzhou Henan, ChinaManufacturer0000api.fda.gov
Leica Biosystems Melbourne Pty LtdMELBOURNE Victoria, AustraliaContract manufacturer0000api.fda.gov
Leica Biosystems Newcastle LtdNewcastle Upon Tyne, United KingdomManufacturer0010api.fda.gov
Lumatas Biosystems, IncMilpitas, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Life Technologies CorporationFrederick, MD, United StatesManufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Metamol TheranosticsMilford, OH, United StatesSpecification developer0000api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Newcomer Supply IncWaunakee, WI, United StatesSpecification developer0000api.fda.gov
Novascope Diagnostics Inc.Zhubei Hsinchu(City), TaiwanExporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
Novodiax, Inc.Hayward, CA, United StatesManufacturer0000api.fda.gov
Pathcom Systems CorporationDublin, CA, United StatesManufacturer0000api.fda.gov
Pathnsitu Biotechnologies Pvt LtdHYDERABAD Telangana, IndiaManufacturer0000api.fda.gov
Proteintech Group IncRosemont, IL, United StatesContract manufacturer0000api.fda.gov
Richard-Allan Scientific LLCKalamazoo, MI, United StatesManufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Sakura Finetek U.s.a., Inc.Torrance, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Scytek Laboratories, Inc.Logan, UT, United StatesManufacturer0000api.fda.gov
Shenzhen Dakewe Bio-Engineering Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Dartmon Biotechnology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shijiazhuang Hipro Biotechnology Co.,ltdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Sienna Cancer Diagnostics LimitedMelbourne Victoria, AustraliaSpecification developer0000api.fda.gov
Ventana Medical Systems, Inc.Tucson, AZ, United StatesManufacturer, Manufacturer for export0032api.fda.gov
Wavesense, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Zeta CorporationMonrovia, CA, United StatesManufacturer0000api.fda.gov
Zhejiang Gene Science Co., Ltdshaoxing Zhejiang, ChinaManufacturer0000api.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.