BION MYCOPLASMA PNEUMONIAE ANTIGEN SUBSTRATE SLIDES 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	LQG
FDA Classification Name	DNA-REAGENTS, MYCOPLASMA SPP.
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3375
FDA Common Generic Name	MYCOPLASMA PNEUMONIAE SUBSTRATE SLIDES FOR IMMUNOFLUOESCENT TESTING
FDA Proprietary Device Name	BION MYCOPLASMA PNEUMONIAE ANTIGEN SUBSTRATE SLIDES
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	05-20-99
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	BECTON, DICKINSON & CO. 7 LOVETON CIR. SPARKS, MD 21152 US 201-847-6800 / 410-316-4000 4099	BD PROBETEC ET MYCOPLASMA ASSAY	BD PROBETEC ET MP ASSAY
2	GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 US 858-410-8000 / 858-410-8891	GEN-PROBE RAPID DIAGNOSTIC SYSTEM MYCOPLASMA PNEUMONIAE	MYCOPLASMA PNEUMONIAE