MASS TRAK IMMUNOSUPPRESSANTS KIT MANUFACTURED BY WATERS CORPORATION

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Request for Information Form	Contact Information
Company Name	WATERS CORPORATION
Address	34 MAPLE ST.
City, State, Zip	MILFORD, MA 01757
Country	US
FDA Owner/Operator Phone	508-478-2000
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	TACROLIMUS TEST SYSTEM
FDA Proprietary Device Name	MASS TRAK IMMUNOSUPPRESSANTS KIT
FDA Owner / Operator Number	1218959
FDA Owner / Operator Name	WATERS CORPORATION
FDA Establishment Registration Number	1218959
FDA Registered Establishment Name	WATERS CORPORATION
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	06-26-07
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	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US / 610-240-3829	ARCHITECT TRACROLIMUS ASSAY	TRACROLIMUS TEST SYSTEM
5	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)
6	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)