CMV-G IFA TEST SYSTEM MANUFACTURED BY BION ENTERPRISES, LTD.

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Request for Information Form	Contact Information
Company Name	BION ENTERPRISES, LTD.
Address	455 STATE STREET, SUITE 100
City, State, Zip	DES PLAINES, IL 60016
Country	US
FDA Owner/Operator Phone	847-544-5044
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	GQH
FDA Classification Name	ANTIGEN, CF (INCLUDING CF CONTROL), CYTOMEGALOVIRUS
FDA Device Classification Code	Standards
FDA Regulation Number	866.3175
FDA Common Generic Name	CMV IGG ANTIBODY DETECTION BY IFA TESTS
FDA Proprietary Device Name	CMV-G IFA TEST SYSTEM
FDA Owner / Operator Number	1419968
FDA Owner / Operator Name	BION ENTERPRISES, LTD.
FDA Establishment Registration Number	1419968
FDA Registered Establishment Name	BION ENTERPRISES, LTD.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	03-28-05
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	ARGENE SA PARC TECHNOLOGIQUE DELTA SUD VARILHES, 09120 FR 335- 61-69 61 00 / 516-795-5583	ARGENE CINAKIT CMV ANTIGENEMIA	ARGENE CINAKIT CMV ANTIGENEMIA
2	GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309	IMMUNODOT T.E.C.H. TEST	ENZYME-LINKED DOT-BLOT IMMUNOASSAY-CMV
3	INSTITUT VIRION AG WEINGARTENSTRASSE 9, RUSCHLIKON, CH-8803 SZ / 973-993-8219	CYTOMEGALOVIRUS	CYTOMEGALOVIRUS
4	MILLIPORE CORPORATION 28820 SINGLE OAK DR. TEMECULA, CA 92590 US 978-715-1399 / 978-715-1399	CYTOMEGALOVIRUS	CYTOMEGALOVIRUS