ESCHERICHIA COLI 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	GMZ
FDA Classification Name	ANTIGENS, ALL TYPES, ESCHERICHIA COLI
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3255
FDA Common Generic Name	E.COLI
FDA Proprietary Device Name	ESCHERICHIA COLI 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	DENKA SEIKEN CO., LTD (NIIGATA FACILITY) 1-2-2, MINAMI HONCHO GOSEN-SHI, NIIGATA, 959-1695 JA 81-3-36699421 / 81-250-420812	VTEC-RPLA " SEIKEN"	ESCHERIHIA COLI VEROTOXIN DETECTION KIT BY REVERSED PASSIVE LATEX AGGLUTINATION
2	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	E-COLI MULTIPLE DIAGNOSIS PRODUCTS	E-COLI MULTIPLE DIAGNOSIS PRODUCTS
3	IVD RESEARCH, INC. 5909 SEA LION PLACE, SUITE D CARLSBAD, CA 92008 US 760-929-7744 / 760-929-7744	E. COLI 0157 STOOL ANTIGEN ELISA	E. COLI 0157 STOOL ANTIGEN ELISA
4	KALYX BIOSCIENCES, INC. 20 CAMELOT DR. NEPEAN ONTARIO, K2G 5X8 CA	RAPITEST E. COLI 0157	RAPITEST E. COLI 0157
5	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229	ANTIGENS, ALL TYPES, ESCHERICHIA COLI	ANTIGENS, ALL TYPES, ESCHERICHIA COLI
6	PRO-LAB, INC. 20 MURAL ST., #4 RICHMOND HILL, ONTARIO, L4B 1K3 CA 905-731-0300 / 905-731-0300	PROLEX E. COLI 0157 LATEX KIT, E. COLIPRO 0157 TM KIT	E. COLI 0157 LATEX KIT
7	REMEL EUROPE LTD REMEL HOUSE, CLIPPER BLVD. WEST CROSSWAYS DARTFORD, KENT, DA2 6PT UK 412-490-8425 / 412-490-8425	E. COLI 0157 ELISA SEROLOGICAL REAGENTS	E. COLI 0157 ELISA SEROLOGICAL REAGENTS