EUROIMMUN ANTI-INFLUENZA 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	GNS
FDA Classification Name	ANTISERA, HAI, INFLUENZA VIRUS A, B, C
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3330
FDA Common Generic Name	ANTI-INFLUENZA ANTIBODY TEST
FDA Proprietary Device Name	EUROIMMUN ANTI-INFLUENZA 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

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1	BION ENTERPRISES, LTD. 455 STATE STREET, SUITE 100 DES PLAINES, IL 60016 US 847-544-5044 / 847-544-5044	INFLUENZA A OR B IFA SLIDES	INFLUENZA TYPE A OR B SUBSTRATES FOR IFA TESTS
2	CARE DIAGNOSTICA GMBH 8 ROEMERSTRASSE MOELLERSDORF, 2513 AU 43-225-255150 / 541-850-9402	CARE FLU, CARE INFLUENZA	FLU TEST
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4	QUIDEL CORP. 10165 MCKELLAR CT. SAN DIEGO, CA 92121 US 858-552-1100 / 858-552-1100 7910	QUICKVUE (R) INFLUENZA TEST	INFLUENZA TEST