QUANTA LITE MANUFACTURED BY INOVA DIAGNOSTICS, INC.

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Request for Information Form	Contact Information
Company Name	INOVA DIAGNOSTICS, INC.
Address	9900 OLD GROVE RD.
City, State, Zip	SAN DIEGO, CA 92131
Country	US
FDA Owner/Operator Phone	858-586-9900
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	NBT
FDA Classification Name	ANTIBODIES,SACCHAROMYCES CEREVISIAE (S.CEREVISIAE)
FDA Device Classification Code	Standards
FDA Regulation Number	866.5785
FDA Common Generic Name	ASCA (S. CEREVIAIAE) IGG ELISA KIT
FDA Proprietary Device Name	QUANTA LITE
FDA Owner / Operator Number	2026994
FDA Owner / Operator Name	INOVA DIAGNOSTICS, INC.
FDA Establishment Registration Number	2026994
FDA Registered Establishment Name	INOVA DIAGNOSTICS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	08-21-00
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	AESKU.DIAGNOSTICS MIKROFORUM RING 2 WENDELSHEIM, D-55234 GM 49-673-496270 / 678-491-4612	AESKULISA, MULTIPLE	MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
2	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	BINDAZYME HUMAN ASCA IGG/IGA ELISA KIT	ASCA ELISA KIT