ENTAMOEBA HISTOLYTICA 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	KHW
FDA Classification Name	ANTIGEN, ID, HA, CEP, ENTAMOEBA HISTOLYTICA & REL. SPP.
FDA Device Classification Code	Standards
FDA Regulation Number	866.3220
FDA Common Generic Name	ENTAMOEBA HISTOLYTICA
FDA Proprietary Device Name	ENTAMOEBA HISTOLYTICA 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

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	BIOVIR LABORATORIES, INC. 685 STONE RD., UNIT 6 BENICIA, CA 94510 US 707-747-5906 / 707-747-5906	GIARDETEC	DIRECT FLUORESCENT ANTIBODY REAGENT KIT FOR GIARDIA LAMLIA
2	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	ENTAMOEBA HISTOLYTICA MULTIPLE DIAGNOSIS PRODUCTS	ENTAMOEBA HISTOLYTICA MULTIPLE DIAGNOSIS PRODUCTS
3	MILLIPORE CORPORATION 28820 SINGLE OAK DR. TEMECULA, CA 92590 US 978-715-1399 / 978-715-1399	AMEBIASIS KIT	ENTAMOEBA HISTOLYTICA ELISA KIT
4	R-BIOPHARM AG LANDWEHRSTRASSE 54 D-64293, DARMSTADT, GM 49-615-1810215 / 49-615-1810215	RIDASCREEN ENTAMOEBA	ANTIGEN, ID, HA, CEP, ENTAMOEBA HISTOLYTICA & REL.SPP
5	REMEL EUROPE LTD REMEL HOUSE, CLIPPER BLVD. WEST CROSSWAYS DARTFORD, KENT, DA2 6PT UK 412-490-8425 / 412-490-8425	TREND AMEBIASIS (ENTAMOEBA HISTOLYTICA) SEROLOGICAL ELISA TEST	AMEBIASIS SERUM ANTIBODY ELISA TEST KIT
6	TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. BLACKSBURG, VA 24060 US 540-953-1664 / 540-953-1664 3004	ENTAMOEBA TEST	ENTAMOEBA TEST