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	MID
FDA Classification Name	SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5660
FDA Common Generic Name	VARIOUS
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	05-16-97
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	AESKU.DIAGNOSTICS MIKROFORUM RING 2 WENDELSHEIM, D-55234 GM 49-673-496270 / 678-491-4612	AESKULISA, MULTIPLE	ANTICARDIOLIPIN IMMUNOLOGICIAL TEST SYSTEM
2	CHESHIRE DIAGNOSTICS LTD. 7 ELM ST. ELLESMERE PORT, CH65 2AU UK 44-151-3488023 / 44-151-3488023	QACA IGG & IGM ELISA KIT	ANTICARDIOLIPIN IGG & IGM ELISA KIT
3	CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130	REAADS II ANTI-CARDIOLIPIN ANTI-BETA 2 GLYCOPROTEIN I ANTI-PHOSPHATIDLESERINE AN	ANTI-CARDIOLIPIN ANTIBODY ENZYME IMMUNOASSAY ANTI-B2GPI ANTIBODY ENZYME IMMUNOAS
4	DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US 305-324-2300 / 305-324-2354	IS-ANTI-CARDIOLIPIN IGG, IGM, IGA AND SCREEN	ANTI-CARDIOLIPIN ANTIBODY ELISA TEST
5	EURO-DIAGNOSTICA AB MEDEON MALMO, S-205 12 SW / +46-40-32 11 00	DIASTAT ATNTICARDIOLIPIN ISA ELUA HIT	INDIRECT ELUA FOR THE DETECTION OF THE ISA CLASS OF AUTOANTIBODIES
6	GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309	MULTIPLE	VARIOUS
7	HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111	AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA	AUTOSTAT II ACA SCREEN ELISA
8	IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D SACRAMENTO, CA 95827 US 916-363-2649 / 916-363-2649	RELISA (R) CARDIOLIPIN IGM ANTIBODY TEST SYSTEM	ANTI - CARDIOLIPIN TEST KIT
9	LOUISVILLE APL DIAGNOSTICS, INC. 2622 NASA PKWY., STE. G2 SEABROOK, TX 77586 US 770-455-7129 / 770-455-7129	APHL ELISA KIT	ELISA KIT
10	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	MULTIPLE CARDIOLIPIN ELISA KITS	VARIOUS
11	ORGENTEC DIAGNOSTIKA GMBH CARL-ZEISS-STRASSE 49 MAINZ, 55129 GM 011-49-613192580 / 763-780-2955	MULTIPLE	VARIOUS
12	PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278	MULTIPLE	VARIOUS TYPES OF ANTI CARDIOLIPON ANTIBODIES ASSAYS
13	QUEST INTL., INC. 1938 N.E. 148TH TERR. NORTH MIAMI, FL 33181 US 305-948-8788 / 305-948-8788	SERAQUEST ANTI-CARDIOLIPIN IGG	ANTI-CARDIOLIPIN IGG SEROLOGICAL REAGENTS
14	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	CARDIOLIPIN EIA KIT IGG, IGA, IGMT SCREEN	CARDIOLIPIN EIA KIT IGG, IGA, IGMT SCREEN
15	THERATEST LABORATORIES, INC. 1111 N. MAIN ST. LOMBARD, IL 60148 US 630-627-6069 / 630-627-6069	EL-ACA	ENZYME IMMUNOASSAY FOR CARDIOLIPIN ANTIBODIES (ACA)
16	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	MULTIPLE	VARIOUS TYPES OF ANTICARDIOLIPIN ELISA TEST KITS
17	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901	ZEUS ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM	ANTI-CARDIOLIPIN TEST SYSTEM