Data / Medical devices / Stain, Papanicolau

Stain, Papanicolau (HZJ): 26 FDA-registered makers in 5 countries

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

26 establishments in 5 countries are registered with the FDA to make Stain, Papanicolau (product code HZJ, Class 1, 21 CFR 864.1850). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on October 2, 1984, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

Country	Makers
United States	19
China	4
Canada	1
Germany	1
South Korea	1

Makers of Stain, Papanicolau

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	Recall events	Source
Azer Scientific, Inc.	Morgantown, PA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Biogenex Laboratories Inc.	Fremont, CA, United States	Manufacturer	0	api.fda.gov
Chaptec America	Montreal Quebec, Canada	Manufacturer	0	api.fda.gov
E K Industries, Inc.	Joliet, IL, United States	Manufacturer	0	api.fda.gov
ENG Scientific LLC	New Brunswick, NJ, United States	Manufacturer	0	api.fda.gov
Ethos Biosciences, INC.	Logan Township, NJ, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Hangzhou Healthsky Biotechnology Co., Ltd.	Hangzhou City Zhejiang, China	Manufacturer	0	api.fda.gov
Hologic, Inc.	Marlborough, MA, United States	Specification developer	0	api.fda.gov
Hologic, Inc.	Londonderry, NH, United States	Manufacturer	0	api.fda.gov
Jinan Babio Biotechnology Co.,ltd.	Jinan City Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Leica Biosystems Richmond, Inc.	Richmond, IL, United States	Manufacturer	0	api.fda.gov
Medical Chemical Corporation	Torrance, CA, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Merck Kgaa	DARMSTADT Hesse, Germany	Manufacturer	0	api.fda.gov
Newcomer Supply Inc	Waunakee, WI, United States	Specification developer	0	api.fda.gov
Noul Co., Ltd.	Yongin Si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
Ricca Chemical Company LLC	Pocomoke City, MD, United States	Manufacturer	0	api.fda.gov
Ricca Chemical Company LLC	Arlington, TX, United States	Manufacturer	0	api.fda.gov
Ricca Chemical Company LLC	Batesville, IN, United States	Manufacturer	0	api.fda.gov
Richard-Allan Scientific LLC	Kalamazoo, MI, United States	Contract manufacturer, Manufacturer	1	api.fda.gov
Sigma-Aldrich Manufacturing, LLC-H&H	Saint Louis, MO, United States	Manufacturer	0	api.fda.gov
SLMP LLC d.b.a. StatLab Medical Products	McKinney, TX, United States	Manufacturer	0	api.fda.gov
SSN Solutions	Henrico, VA, United States	Manufacturer	0	api.fda.gov
Transene Company, Inc.	Danvers, MA, United States	Manufacturer	0	api.fda.gov
Volusol	Tooele, UT, United States	Manufacturer	0	api.fda.gov
Wuhan Landing Intelligence Medical Co.,Ltd	Wuhan Hubei, China	Manufacturer	0	api.fda.gov
Zhejiang Gene Science Co., Ltd	shaoxing Zhejiang, China	Manufacturer	0	api.fda.gov

Updated October 2, 1984. 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.