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	MQA
FDA Classification Name	ANTI-RIBOSOMAL P ANTIBODIES
FDA Device Classification Code	Standards
FDA Regulation Number	866.5100
FDA Common Generic Name	RIBOSOME P 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	06-16-98
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	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263	BIOPLEX 2200 ANA SCREEN	ANA SCREENING TEST
2	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	RIBOSOMAL P ELISA	RIBOSOMAL P ELISA
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4	WUJIANG JIA CHEN ACUPUNCTURE DEVICES CO., LTD. NO.8 LI MIN SOUTH RD., LILI TOWN WUJIANG CITY, JIANGSU PROVINCE, 215212 CH 86-512-63612822 / 626-336-3036	JIA CHEN, A'ONE, AMAX ACUPUNCTURE NEEDLE	ACUPUNCTURE NEEDLES