CEDIA TACROLIMUS ASSAY (INCLUDES CALIBRATORS) MANUFACTURED BY MICROGENICS CORP.

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Request for Information Form	Contact Information
Company Name	MICROGENICS CORP.
Address	46360 FREMONT BLVD
City, State, Zip	FREMONT, CA 94538
Country	US
FDA Owner/Operator Phone	412-490-8425
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	CEDIA TACROLIMUS ASSAY (INCLUDES CALIBRATORS)
FDA Proprietary Device Name	CEDIA TACROLIMUS ASSAY (INCLUDES CALIBRATORS)
FDA Owner / Operator Number	2517925
FDA Owner / Operator Name	FISHER SCIENTIFIC CO., LLC.
FDA Establishment Registration Number	2937369
FDA Registered Establishment Name	MICROGENICS CORP.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-01-05
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	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US / 610-240-3829	ARCHITECT TRACROLIMUS ASSAY	TRACROLIMUS TEST SYSTEM
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