EUROIMMUN ANTI-COXSACKIEVIRUS KIT 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	GNM
FDA Classification Name	ANTISERA, FLUORESCENT, COXSACKIEVIRUS A 1-24, B 1-6
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3145
FDA Common Generic Name	ANTI-COXSACKIEVIRUS KIT
FDA Proprietary Device Name	EUROIMMUN ANTI-COXSACKIEVIRUS KIT
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	12-21-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	CEPHEID 904 CARIBBEAN DRIVE SUNNYVALE, CA 94089 US 408-400-8460 / 408-400-8230	XPERT EV, GENEXPERT DX SYSTEM AND SOFTWARE	NUCLEIC ACID AMPLIFICATION TEST
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3	MILLIPORE CORPORATION 28820 SINGLE OAK DR. TEMECULA, CA 92590 US 978-715-1399 / 978-715-1399	LIGHT DIAGNOSTICS ENTEROVIRUSMONOCLANTIBODYCOXSACKA9, B1-6	COXSACKIEVIRUS SEROLOGICAL REAGENTS