EUROIMMUN ANTI-BORDETELLA 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	GOZ
FDA Classification Name	ANTISERA, FLUORESCENT, B. PERTUSSIS
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3065
FDA Common Generic Name	ANTI-BORDETELLA KIT
FDA Proprietary Device Name	EUROIMMUN ANTI-BORDETELLA 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	COMBINED INSTRUMENTS (PVT.), LTD. 13-A MODEL TOWN, UGOKI SAILKOT, PK 04-32-510243 / 05-24-510243	ANTISERA, FLUORESCENT, B. PERTUSSIS	SAME
2	LEE LABORATORIES, INC. 1475 ATHENS HWY. GRAYSON, GA 30017 US 201-847-6800 / 410-316-4000 4099		BORDETELLA PERTUSSIS FLUORESCENT GLOBULIN