GOAT ANTISERA TO HUMAN ALPHA-FETOPROTEIN MANUFACTURED BY BECKMAN COULTER, INC.

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Request for Information Form	Contact Information
Company Name	BECKMAN COULTER, INC.
Address	1000 LAKE HAZELTINE DR.
City, State, Zip	CHASKA, MN 55318
Country	US
FDA Owner/Operator Phone	714-871-4848
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	DCO
FDA Classification Name	ALPHA-GLOBULIN, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	General Controls
FDA Regulation Number	866.5400
FDA Common Generic Name	GOAT ANTISERA TO HUMAN ALPHA-FETOPROTEIN
FDA Proprietary Device Name	GOAT ANTISERA TO HUMAN ALPHA-FETOPROTEIN
FDA Owner / Operator Number	2050012
FDA Owner / Operator Name	BECKMAN COULTER, INC.
FDA Establishment Registration Number	2122870
FDA Registered Establishment Name	BECKMAN COULTER, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date
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 companyies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	NA ALPHA-1- MICROGLOBULIN KIT	ANTISERUM TO HUMAN ALPHA-GLOBULIN