RESPIRATORY SYNCYTIAL VIRUS 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	MCE
FDA Classification Name	RESPIRATORY SYNCYTIAL VIRUS - ELISA
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3480
FDA Common Generic Name	RSV
FDA Proprietary Device Name	RESPIRATORY SYNCYTIAL VIRUS 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)	RR - Repackager/Relabeller
FDA Listing Date	09-09-05
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	CHEMBIO DIAGNOSTIC SYSTEMS, INC. 3661 HORSEBLOCK RD. MEDFORD, NY 11763 US 631-924-1135 / 631-924-1135	RAPID RSV DIPSTICK	RAPID IMMUNOCHROMATOGRAPHIC TEST FOR DETECTION OF RSV IN HUMAN RESPIRATORY SAMPL
2	GENZYME VIROTECH GMBH LOEWENPLATZ 5 RUSSELSHEIM, D-65428 GM 617-252-7500 / 617-252-7500	RSV ELISA ASSAY	RSV ELISA ASSAY
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