GAMMA GLOBULIN, FLUORESCEIN CONJUGATED ANTISERA 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	DAF
FDA Classification Name	GAMMA GLOBULIN, FITC, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5510
FDA Common Generic Name	GAMMA GLOBULIN, FLUORESCEIN CONJUGATED ANTISERA
FDA Proprietary Device Name	GAMMA GLOBULIN, FLUORESCEIN CONJUGATED ANTISERA
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	AMICO LAB, INC. 5012 ILLINOIS AVE. P.O. BOX 90203 NASHVILLE, TN 37209 US 615-385-7711 / 615-385-7711		FITC GOAT ANTI-HUMAN GLOBULIN ANTISERUM