EUROIMMUN ANTI-BRUCELLA ANTIBODY TEST MANUFACTURED BY EUROIMMUN US LLC

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Request for Information Form	Contact Information
Company Name	EUROIMMUN US LLC
Address	429 ROCKAWAY VALLEY RD. UNIT 1200
City, State, Zip	BOONTON, NJ 07005
Country	US
FDA Owner/Operator Phone	973-402-6101
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	GSM
FDA Classification Name	ANTISERA, FLUORESCENT, BRUCELLA SPP.
FDA Device Classification Code	Standards
FDA Regulation Number	866.3085
FDA Common Generic Name	BRUCELLA ANTIBODY TEST
FDA Proprietary Device Name	EUROIMMUN ANTI-BRUCELLA ANTIBODY TEST
FDA Owner / Operator Number	9066845
FDA Owner / Operator Name	EUROIMMUN US LLC
FDA Establishment Registration Number	3004754465
FDA Registered Establishment Name	EUROIMMUN US LLC
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	09-21-06
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	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
2	GENZYME VIROTECH GMBH LOEWENPLATZ 5 RUSSELSHEIM, D-65428 GM 617-252-7500 / 617-252-7500	BRUCELLA IGM ELISA KIT	BRUCELLA IGM ELISA ASSAY
3	GERMAINE LABORATORIES, INC. 4139 GARDENDALE CENTER, SUITE 101 SAN ANTONIO, TX 78229 US 210-692-4192 / 210-692-4192	BRUCELLA ANTISERUM	VARIOUS TYPES OF BRUCELLA ANTISERA
4	IMMUNO RESOURCES, INC. 415 SISTERDALE RD. BOERNE, TX 78006 US 830-537-6199 / 830-537-6199	MULTIPLE	VARIOUS
5	PANBIO LIMITED 532 SEVENTEEN MILE ROCKS RD SINNAMON PARK, QLD, 4073 AS 617-336-37100 / 61-733-637100	BRUCELLA IGG ELISA	BRUCELLA IGG ELISA