Data / Medical devices / Stains, Hematology

Stains, Hematology (KQC): 20 FDA-registered makers in 8 countries

Name: FDA-registered makers of Stains, Hematology
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

20 establishments in 8 countries are registered with the FDA to make Stains, Hematology (product code KQC, Class 1, 21 CFR 864.1850). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on July 28, 1988, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: KQC
Device class: 1
Regulation: 864.1850
Medical specialty: Hematology

Makers by country

Country	Makers
United States	11
Germany	2
Japan	2
India	1
China	1
Taiwan	1
Canada	1
France	1

Makers of Stains, Hematology

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.

Maker	Location	Role	Source
Accuster Technologies Pvt. Ltd.	New Delhi, India	Specification developer	api.fda.gov
Azer Scientific, Inc.	Morgantown, PA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	api.fda.gov
B&e Bio-Technology Co., Ltd.	Yantai Shandong, China	Manufacturer	api.fda.gov
Beckman Coulter, Inc.	Miami, FL, United States	Specification developer	api.fda.gov
Bonraybio Co., Ltd.	Taichung, Taiwan	Manufacturer	api.fda.gov
Cambridge Diagnostic Products, Inc.	Fort Lauderdale, FL, United States	Manufacturer	api.fda.gov
Chaptec America	Montreal Quebec, Canada	Manufacturer	api.fda.gov
Cancer Diagnostics, Inc.	Durham, NC, United States	Manufacturer	api.fda.gov
Ethos Biosciences, INC.	Logan Township, NJ, United States	Contract manufacturer, Manufacturer	api.fda.gov
Merck Kgaa	DARMSTADT Hesse, Germany	Manufacturer	api.fda.gov
One Lambda, Inc.	West Hills, CA, United States	Manufacturer	api.fda.gov
Polysciences, Inc.	Warrington, PA, United States	Contract manufacturer	api.fda.gov
Ral Diagnostics	Martillac Gironde, France	Manufacturer	api.fda.gov
Richard-Allan Scientific LLC	Kalamazoo, MI, United States	Manufacturer	api.fda.gov
SLMP LLC d.b.a. StatLab Medical Products	McKinney, TX, United States	Manufacturer	api.fda.gov
Sysmex Corporation Ono Factory	Ono Hyogo, Japan	Manufacturer	api.fda.gov
Sysmex Corporation Techno Park	KOBE Hyogo, Japan	Specification developer	api.fda.gov
Sysmex Europe SE	Neumunster Schleswig-Holstein, Germany	Manufacturer	api.fda.gov
Volusol	Tooele, UT, United States	Manufacturer	api.fda.gov
Wavesense, Inc.	Irvine, CA, United States	Manufacturer	api.fda.gov

Updated July 28, 1988. 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.