ARCHITECT TRACROLIMUS ASSAY MANUFACTURED BY FUJIREBIO DIAGNOSTICS, INC.

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Request for Information Form	Contact Information
Company Name	FUJIREBIO DIAGNOSTICS, INC.
Address	201 GREAT VALLEY PKWY.
City, State, Zip	MALVERN, PA 19355
Country	US
FDA Owner/Operator Phone	--
FDA Medical Specialty Code	TX - Clinical Toxicology
FDA Product Code	MLM
FDA Classification Name	ENZYME IMMUNOASSAY, TRACROLIMUS
FDA Device Classification Code	Standards
FDA Regulation Number	862.1678
FDA Common Generic Name	TRACROLIMUS TEST SYSTEM
FDA Proprietary Device Name	ARCHITECT TRACROLIMUS ASSAY
FDA Owner / Operator Number	8031611
FDA Owner / Operator Name	FUJIREBIO DIAGNOSTICS, INC.
FDA Establishment Registration Number	2521625
FDA Registered Establishment Name	FUJIREBIO DIAGNOSTICS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	08-23-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	IMX TACROLIMUS (II)	IN VITRO REAGENT TO DETERMINE TACROLIMUS IN BLOOD
2	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	EMIT 2000 TRACROLIMUS ASSAY	TRACROLIMUS ASSAY
3	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	DIMENSION TRACROLIMUS FLEX REAGENT CARTRIDGE	DIMENSION TRACROLIMUS
4	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	CEDIA TACROLIMUS ASSAY (INCLUDES CALIBRATORS)	CEDIA TACROLIMUS ASSAY (INCLUDES CALIBRATORS)
5	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	CEDIA TACROLIMUS ASSAY (INCLUDES CALIBRATORS)	CEDIA TACROLIMUS ASSAY (INCLUDES CALIBRATORS)
6	WATERS CORPORATION 34 MAPLE ST. MILFORD, MA 01757 US 508-478-2000 / 508-482-2545	MASS TRAK IMMUNOSUPPRESSANTS KIT	TACROLIMUS TEST SYSTEM