BRUCELLA SPP. 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	GSO
FDA Classification Name	ANTIGENS (FEBRILE), AGGLUTINATION, BRUCELLA SPP.
FDA Device Classification Code	Standards
FDA Regulation Number	866.3085
FDA Common Generic Name	BRUCELLA
FDA Proprietary Device Name	BRUCELLA SPP. 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	CENOGENICS CORP. 100 RT. 520 MORGANVILLE, NJ 07751 US 732-536-6457 / 732-536-6457	BRUCELLA ABORTUS AND BRUCELLA MELITENSIS ANTIGEN	BRUCELLA ABORTUS AND BRUCELLA MELITENSIS ANTIGEN
2	EGYPTIAN CO. FOR BIOTECHNOLOGY BLDG 19A, BLOCK 20008, STREET 163 OBOUR CITY, CAIRO, EG 2-02-6651848 / 2-02-6651848	SPECTRUM DIAGNOSTICS BRUCELLA SPP REAGENT	BRUCELLA SPP. SEROLOGICAL REAGENT
3	GERMAINE LABORATORIES, INC. 4139 GARDENDALE CENTER, SUITE 101 SAN ANTONIO, TX 78229 US 210-692-4192 / 210-692-4192	MULTIPLE	VARIOUS TYPES
4	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	BRUCELLA MULTIPLE DIAGNOSIS PRODUCTS	BRUCELLA MULTIPLE DIAGNOSIS PRODUCTS
5	IMMUNO RESOURCES, INC. 415 SISTERDALE RD. BOERNE, TX 78006 US 830-537-6199 / 830-537-6199	MULTIPLE	VARIOUS
6	IMMUNOSTICS, INC. 3505 SUNSET AVE. OCEAN, NJ 07712 US / 732-918-0770	BACTERIAL AGGLUTINATION ANTIGENS	RAPID SLIDE & TUBE TEST FOR DETECTION OF BACTERIAL AGGLUTINS
7	LEE LABORATORIES, INC. 1475 ATHENS HWY. GRAYSON, GA 30017 US 201-847-6800 / 410-316-4000 4099	MULTIPLE	VARIOUS FEBRILE (WEIL-FELIX) ANTIGENS
8	REMEL EUROPE LTD REMEL HOUSE, CLIPPER BLVD. WEST CROSSWAYS DARTFORD, KENT, DA2 6PT UK 412-490-8425 / 412-490-8425	MULTIPLE	BRUCELLA STAINED SUSPENSIONS
9	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	MULTIPLE	VARIOUS TYPES OF BRUCELLA ELISA TEST KITS