Data / Medical devices / United States / Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics, Inc.: FDA-registered device maker in Seguin, TX, United States, 3 510(k) clearances

Name: Fujirebio Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fujirebio Diagnostics, Inc. is registered with the FDA (registration 1643621) in Seguin, TX, United States. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 21, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1643621
Address: 940 Crossroads Blvd, Seguin, TX, United States, 78155
Owner or operator: Fujirebio Diagnostics, Inc. (10022860)
Roles: Contract manufacturer, Manufacturer
First device listed: October 17, 2007
Registered through: 2026
Brand names listed: ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens, ADVIA Centaur XPT Tumor Marker Quality Controls (TMQC) - Siemens, ARCHITECT CYFRA 21-1 Controls, ARCHITECT CYFRA 21-1 Controls (China), ARCHITECT CYFRA 21-1 Controls (ROW), ARCHITECT Calibrators (China), ARCHITECT Cyclosporine, ARCHITECT Cyclosporine Calibrators and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Antigens, Ha, Treponema Pallidum	GMT	2	Manufacturer	accessdata.fda.gov
Antiserum, Fluorescent, Rabies Virus	GOI	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Contract manufacturer	accessdata.fda.gov
Cyclosporine	MKW	2	Contract manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Tracrolimus	MLM	2	Contract manufacturer	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
Sirolimus Test System	NRP	2	Contract manufacturer	accessdata.fda.gov
System, Test, Automated Blood Grouping And Antibody	KSZ	2	Contract manufacturer	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 21, 2015	K142895	LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators	LTK	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
November 13, 1997	K971502	SERODIA TP-PA	GMT	Substantially Equivalent	Scimedx Tekfile Services	accessdata.fda.gov
April 16, 1982	K820499	FITC ANTI-RABIES MONOCLONAL GLOBULIN	GOI	Substantially Equivalent	Centocor, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 21, 2015. 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.