EUROIMMUN CANDIDA ALBICAN ANTIBODY TEST 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	LHK
FDA Classification Name	ANTIGEN, ID, CANDIDA ALBICANS
FDA Device Classification Code	Standards
FDA Regulation Number	866.3165
FDA Common Generic Name	CANDIDA ALBICAN ANTIBODY TEST
FDA Proprietary Device Name	EUROIMMUN CANDIDA ALBICAN ANTIBODY TEST
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	11-17-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079	CRYPTOCOCCUS NEOFORMANS SEROLOGICAL REAGENTS	CANDIDA ALBICANS
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