EUROIMMUN ANTI-KLEBSIELLA 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	MI - Microbiology
FDA Product Code	GTC
FDA Classification Name	ANTISERA, ALL TYPES, KLEBSIELLA SPP.
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3340
FDA Common Generic Name	ANTI-KLEBSIELLA KIT
FDA Proprietary Device Name	EUROIMMUN ANTI-KLEBSIELLA 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	DENKA SEIKEN CO., LTD (NIIGATA FACILITY) 1-2-2, MINAMI HONCHO GOSEN-SHI, NIIGATA, 959-1695 JA 81-3-36699421 / 81-250-420812	MULTIPLE	VARIOUS ANTISERA OF KLEBSIELLA
2	MAST GROUP LTD. MAST HOUSE, DERBY RD. BOOTLE, MERSEYSIDE, L20 1EA UK / 441-519-33727	MAST-ASSURE ANTISERA	KLEBSIELLA ANTISERA