LSA 290 ALPHA-1-ACID GLYCOPROTEIN ASSAY 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	DEY
FDA Classification Name	IGM, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5550
FDA Common Generic Name	ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
FDA Proprietary Device Name	LSA 290 ALPHA-1-ACID GLYCOPROTEIN ASSAY
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 companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	KENT LABORATORIES, INC. 777 JORGENSEN PLACE BELLINGHAM, WA 98226 US 360-398-8641 / 360-398-8641	PEROXIDASE CONJUGATED IGM ANTISERUM (MU CHAIN SPECIFIC)	PEROXIDASE CONJUGATED IGM ANTISERUM (MU CHAIN SPECIFIC)
2	VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. TUCSON, AZ 85755 US 520-887-2155 / 520-229-3928	MULTIPLE	VARIOUS IGM PEROXIDASE ANTIGEN ANTISERUM CONTROLS