EUROIMMUN MYCOPLASMA 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	GRZ
FDA Classification Name	ANTISERA, FLUORESCENT, ALL, MYCOPLASMA SPP.
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3375
FDA Common Generic Name	MYCOPLASMA ANTIBODY TEST
FDA Proprietary Device Name	EUROIMMUN MYCOPLASMA 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 companyies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901	MYCOPLASMA PNEUMONIAE ANTIBODY (MP) TEST SYSTEM	MYCOPLASMA PNEUMONIAE FLUORESCENT TEST