IMX TACROLIMUS (II) MANUFACTURED BY ABBOTT LABORATORIES

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Request for Information Form	Contact Information
Company Name	ABBOTT LABORATORIES
Address	100 AND 200 ABBOTT PARK RD.
City, State, Zip	ABBOTT PARK, IL 60064
Country	US
FDA Owner/Operator Phone	847-937-6100
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	IN VITRO REAGENT TO DETERMINE TACROLIMUS IN BLOOD
FDA Proprietary Device Name	IMX TACROLIMUS (II)
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	1415939
FDA Registered Establishment Name	ABBOTT LABORATORIES
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-01-97
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	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	EMIT 2000 TRACROLIMUS ASSAY	TRACROLIMUS ASSAY
2	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
3	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US / 610-240-3829	ARCHITECT TRACROLIMUS ASSAY	TRACROLIMUS TEST SYSTEM
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