CANDIDA ELISA KIT MANUFACTURED BY GENZYME VIROTECH GMBH

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Request for Information Form	Contact Information
Company Name	GENZYME VIROTECH GMBH
Address	LOEWENPLATZ 5
City, State, Zip	RUSSELSHEIM,
Country	GM
FDA Owner/Operator Phone	617-252-7500
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	LSG
FDA Classification Name	CANDIDA SPECIES, ANTIBODY DETECTION
FDA Device Classification Code	Standards
FDA Regulation Number	866.3165
FDA Common Generic Name	CANDIDA ELISA ASSAY
FDA Proprietary Device Name	CANDIDA ELISA KIT
FDA Owner / Operator Number	9002116
FDA Owner / Operator Name	GENZYME CORPORATION
FDA Establishment Registration Number	8010933
FDA Registered Establishment Name	GENZYME VIROTECH GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-15-05
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	DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079	CRYPTOCOCCUS NEOFORMANS SEROLOGICAL REAGENTS	CANDIDA ALBICANS
2	IMMUNO-MYCOLOGICS, INC. 2700 TECHNOLOGY PLACE NORMAN, OK 73071 US 405-360-4669 / 405-360-4669	MULTIPLE	CANDIDA ID, ANTIBODY DETECTION