EUROIMMUN BETA-2-GLYCOPROTEIN 1 KIT MANUFACTURED BY EUROIMMUN US LLC

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Request for Information Form	Contact Information
Company Name	EUROIMMUN US LLC
Address	429 ROCKAWAY VALLEY RD. UNIT 1200
City, State, Zip	BOONTON, NJ 07005
Country	US
FDA Owner/Operator Phone	973-402-6101
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	DDN
FDA Classification Name	BETA-2-GLYCOPROTEIN I, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	General Controls
FDA Regulation Number	866.5430
FDA Common Generic Name	BETA-2- GLYCOPROTEIN 1
FDA Proprietary Device Name	EUROIMMUN BETA-2-GLYCOPROTEIN 1 KIT
FDA Owner / Operator Number	9066845
FDA Owner / Operator Name	EUROIMMUN US LLC
FDA Establishment Registration Number	3004754465
FDA Registered Establishment Name	EUROIMMUN US LLC
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	12-21-06
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	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	MULTIPLE	VARIOUS
2	DYN-BIOSHAF (2006) LTD. 7 HA'ESHEL ST. CAESAREA INDUSTRIAL PARK, 38900 IS 972-4-8202056 / 603-369-3550	FLOW-BETA2GP1- IVD KIT	BETA-2-GLYCOPROTEIN I IMMUNOLOGICAL TEST SYSTEM
3	STAGO R & D 125 AVE. LOUIS ROCHE GENNEVILLIERS, 92230 FR 33-146-88 20 20 / 33-146-854851	BETA 2 GLYCOPROTEIN 1, HUMAN	BETA 2 GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL