EUROIMMUN MUMPS 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	GRA
FDA Classification Name	ANTISERUM, FLUORESCENT, MUMPS VIRUS
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3380
FDA Common Generic Name	MUMPS ANTIBODY TEST
FDA Proprietary Device Name	EUROIMMUN MUMPS 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	11-17-06
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	BION ENTERPRISES, LTD. 455 STATE STREET, SUITE 100 DES PLAINES, IL 60016 US 847-544-5044 / 847-544-5044	MUMPS-G IFA TEST SYSTEM	MUMPS IGG ANTIBODY DETECTION BY IFA TESTS
2	HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501	VIRGO MUMPS	MUMPS VIRUS
3	MILLIPORE CORPORATION 28820 SINGLE OAK DR. TEMECULA, CA 92590 US 978-715-1399 / 978-715-1399	MUMPS INDIRECT IMMUNOFLUORESCENT ASSAY & CONTROL SLIDES	MUMPS INDIRECT IMMUNOFLUORESCENT ASSAY & CONTROL SLIDES