Data / Medical devices / Fibrin Split Products

Fibrin Split Products (GHH): 17 FDA-registered makers in 6 countries

Name: FDA-registered makers of Fibrin Split Products
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 6 countries are registered with the FDA to make Fibrin Split Products (product code GHH, Class 2, 21 CFR 864.7320). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on January 24, 2013, and lists 9 recall events (1 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 device Makers in the United States Watch this device

Product code: GHH
Device class: 2
Regulation: 864.7320
Medical specialty: Hematology

Makers by country

Country	Makers
United States	8
Japan	4
Germany	2
Ireland	1
France	1
Switzerland	1

Makers of Fibrin Split Products

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	510(k) clearances	Latest clearance	Recall events	Source
Fisher Diagnostics	Middletown, VA, United States	Manufacturer, Repackager or relabeler	2	October 16, 1992	1	api.fda.gov
Beckman Coulter Ireland Inc	O CALLAGHANS MILLS Clare, Ireland	Manufacturer	1	June 11, 2007	0	api.fda.gov
Diagnostica Stago - Taverny	Taverny Val-d'Oise, France	Exporter to the US, Manufacturer	1	February 7, 1989	0	api.fda.gov
Diazyme Laboratories, Inc.	Poway, CA, United States	Manufacturer	1	January 24, 2013	0	api.fda.gov
PHC Corporation	Tako-machi Katori-gun Chiba, Japan	Complaint file establishment, Specification developer	1	May 6, 2009	0	api.fda.gov
Quidel Cardiovascular Inc.	San Diego, CA, United States	Manufacturer	1	November 29, 2004	0	api.fda.gov
Roche Diagnostics GMBH	MANNHEIM Baden-Wurttemberg, Germany	Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer	1	March 14, 2007	0	api.fda.gov
Epitope Diagnostics, Inc.	San Diego, CA, United States	Manufacturer for export	0		0	api.fda.gov
High Technology, Inc.	North Attleboro, MA, United States	Manufacturer for export	0		0	api.fda.gov
Kamiya Biomedical Company LLC	Tukwila, WA, United States	Manufacturer	0		0	api.fda.gov
Nipro Corporation Odate Factory	ODATE-SHI Akita, Japan	Contract manufacturer	0		0	api.fda.gov
Roche Diagnostics GMBH	PENZBERG Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Roche Diagnostics International Ltd.	ROTKREUZ Zug, Switzerland	Manufacturer	0		0	api.fda.gov
Shima Laboratories Co., Ltd.	ITABASHI-KU Tokyo, Japan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Newark, DE, United States	Manufacturer	0		1	api.fda.gov
Siemens Healthcare Diagnostics Inc	East Walpole, MA, United States	Specification developer	0		0	api.fda.gov
Tosoh Aia, Inc.	Toyama, Japan	Manufacturer	0		0	api.fda.gov

Updated January 24, 2013. 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.