CRYPTOCOCCUS NEOFORMANS SEROLOGICAL REAGENTS MANUFACTURED BY DRG INSTRUMENTS GMBH

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Request for Information Form	Contact Information
Company Name	DRG INSTRUMENTS GMBH
Address	FRAUENBERGSTRASSE 18
City, State, Zip	MARBURG,
Country	GM
FDA Owner/Operator Phone	908-233-2079
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 ALBICANS
FDA Proprietary Device Name	CRYPTOCOCCUS NEOFORMANS SEROLOGICAL REAGENTS
FDA Owner / Operator Number	2245285
FDA Owner / Operator Name	DRG INTL., INC.
FDA Establishment Registration Number	3002800697
FDA Registered Establishment Name	DRG INSTRUMENTS GMBH
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	08-08-05
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	EUROIMMUN US LLC 429 ROCKAWAY VALLEY RD. UNIT 1200 BOONTON, NJ 07005 US 973-402-6101 / 973-402-6101	EUROIMMUN CANDIDA ALBICAN ANTIBODY TEST	CANDIDA ALBICAN ANTIBODY TEST
2	IMMUNO-MYCOLOGICS, INC. 2700 TECHNOLOGY PLACE NORMAN, OK 73071 US 405-360-4669 / 405-360-4669	CANDIDA IMMUNODIFFUSION (ID) KIT	IMMUNODIFFUSON (ID) KIT
3	RAMCO LABORATORIES, INC. 4100 GREENBRIAR DR., SUITE 200 STAFFORD, TX 77477 US 281-313-1200 / 800-231-6238	CAND-TEC CANDIDA ALBICANS	LATEX AGGLUTINATION TEST FOR THE DETECTION OF CANDIDA ANTIGEN