QUANTA LITE MANUFACTURED BY INOVA DIAGNOSTICS, INC.

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QUANTA LITE

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	MSV
FDA Classification Name	SYSTEM,TEST,ANTIBODIES,B2 - GLYCOPROTEIN I (B2 - GPI)
FDA Device Classification Code	Standards
FDA Regulation Number	866.5660
FDA Common Generic Name	BETA 2 GPI 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	07-08-97
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of INOVA DIAGNOSTICS, INC.

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	AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE STAMFORD, CT 06902 US 203-602-7777 / 203-602-7777	IMUCLONE ANTI-BETA 2 IGG,IGM ELISA	ANTI-BETA 2 IGG,IGM ELISA
2	CHESHIRE DIAGNOSTICS LTD. 7 ELM ST. ELLESMERE PORT, CH65 2AU UK 44-151-3488023 / 44-151-3488023	QAB2A IGM ELISA KIT	ANTI B2-GLYCOPROTEIN 1 IGM/IGA ELISA KITS
3	CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130	REAADS IGM IGG IGA ANTI-B2GPI TEST KITS	ANTI-B2GPI ENZYME IMMUNOASSAY TEST KIT
4	DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US 305-324-2300 / 305-324-2354	IS-ANTI-BETA2 GLYCOPROTEIN I IGG, IGM, AND SCREEN	ANTI-BETA 2 GLYCOPROTEIN ANTIBODY ELISA TEST
5	EURO-DIAGNOSTICA AB MEDEON MALMO, S-205 12 SW / +46-40-32 11 00	DIASTAT B2GD1-IGG KIT, DIASTAT B2CP1-ISM KIT	ELISA FOR THE DETECTION OF ISC ANTIBODIES TO B2CP1 ANTIGEN ISM
6	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	MULTIPLE	VARIOUS
7	HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111	AUTOSTAT TM II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA	AUTOSTAT TM II ANTI-B-2 GPI IGM ELISA
8	LOUISVILLE APL DIAGNOSTICS, INC. 2622 NASA PKWY., STE. G2 SEABROOK, TX 77586 US 770-455-7129 / 770-455-7129	EL-B2GP1	LAPL-K-HRP-AB2GPI
9	PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278	MULTIPLE	SYSTEM, TEST, ANTIBODIES, B2-GLYCOPROTEIN I (B2-GPI)
10	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	BETA-2 GPI IGG EIA KIT	BETA-2 GPI IGG EIA KIT
11	THERATEST LABORATORIES, INC. 1111 N. MAIN ST. LOMBARD, IL 60148 US 630-627-6069 / 630-627-6069	EL-B2 GP1	BETA 2 GP1 ANTIBODY ELISA TEST