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	NHX
FDA Classification Name	ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
FDA Device Classification Code	Standards
FDA Regulation Number	866.5775
FDA Common Generic Name	CCP IGG ELISA
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	05-07-02
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	AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND, DD2 1XA UK 44-13-82 422000 / 441-382-422000	DIASTAT (TM) ANTI-CYCLE CITRULLINATED PEPTIDE (ANTI-CCP) ELISA	DIASTAT (TM) ANTI-CCP ELISA
2	EURO-DIAGNOSTICA AB MEDEON MALMO, S-205 12 SW / +46-40-32 11 00	IMMUNOSCAN RA ANTI-CCP TEST KIT	IMMUNOSCAN RA ANTI-CCP ELISA
3	PHADIA AB RAPSGATAN 7 UPPSALA, SE-754 50 SW 46-18-165000 / 46-18-163775	ELIA CCP, ELIA CCP CONTROL	ANTI CCP ANTIBODIES, ANTIGEN AND CONTROL