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MULTIPLE
 Request for Information Form |
 Contact Information
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| 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 | LLL |
| FDA Classification Name | EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.5100 |
| FDA Common Generic Name | VARIOUS |
| FDA Proprietary Device Name | MULTIPLE |
| 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 | ANTIOBODY TEST KIT, ELISA |
| 2 | BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG MARNE LA VALLEE CEDEX 2, 77435 FR 33-164-621012 / 33-166-621012 |
FIDIS TM CONNECTIVE 10 | IMMUNOLOGICAL TEST SYSTEM |
| 3 | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263 |
MULTIPLE | EIA ENA TEST KITS |
| 4 | CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130 |
MULTIPLE | SCI-70, SS-A, SS-B, JO-1 |
| 5 | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US 305-324-2300 / 305-324-2354 |
ANTI-JO-1 MICROASSAY | MULTIPLE |
| 6 | EURO-DIAGNOSTICA AB MEDEON MALMO, S-205 12 SW / +46-40-32 11 00 |
DIASTAT ENA SINGLE WELL SCREEN | ELISA FOR DETECTION OF AUTOANTIBODIES TO EXTRACTABLE NUCLEAR ANTIGEM |
| 7 | GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309 |
IMMUNOWELL SSA/B ANTIBODY TEST KIT | ENZYME - LINKED IMMUNOASSAY - FOR SSA/B ANTIBODIES |
| 8 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
ENA SCREENING CIE KIT FOR D MULTIPLE DIAGNOSIS PRODUCTS | ENA SCREENING CIE KIT FOR D MULTIPLE DIAGNOSIS PRODUCTS |
| 9 | HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111 |
MULTIPLE | VARIOUS |
| 10 | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US 716-691-0091 / 716-691-0091 |
IMMCO DIAGNOSTICS IMMUGEL ANTI-SCL-70 ANTIBODY ASSAY | ANTI SCL 70 ANTIBODY ASSAY |
| 11 | IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D SACRAMENTO, CA 95827 US 916-363-2649 / 916-363-2649 |
RELISA (R) ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM | ENA SINGLE WELL SCREEN ANTIBODY TEST KIT |
| 12 | MARDX DIAGNOSTICS, INC. 5919 FARNSWORTH CT. CARLSBAD, CA 92008 US 353-127-69800 / 716-483-3851 1030 |
ENA TEST SYSTEM, MULTIPLE | ENA TEST SYSTEM, MULTIPLE |
| 13 | MBL INTERNATIONAL CORP. 15 B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964 |
MESACUP-2 TEST CENP-B | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL TEST SYSTEM |
| 14 | MBL INTERNATIONAL CORPORATION 15B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964 |
MESACUP-2 TEST | MULTIPLE ANTI-SS-A, SS-B, SCL-70 AND JO-1 |
| 15 | MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 TUSTIN, CA 92780 US 714-832-8234 / 714-832-8234 |
MDI-SS-B TEST | ELISA TEST SEROLOGY |
| 16 | ORGENTEC DIAGNOSTIKA GMBH CARL-ZEISS-STRASSE 49 MAINZ, 55129 GM 011-49-613192580 / 763-780-2955 |
ORGENTEC ENASCREEN ELISA ASSAY | ENASCREEN ENZYME IMMUNOASSAY |
| 17 | PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278 |
MULTIPLE | ANTINUCLEAR ANTIBODIES, ANTIGEN AND CONTROL |
| 18 | QUEST INTL., INC. 1938 N.E. 148TH TERR. NORTH MIAMI, FL 33181 US 305-948-8788 / 305-948-8788 |
SERAQUEST ANTI-SSB | ANTI-SB SEROLOGICAL REAGENTS, ELISA |
| 19 | THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000 |
ENA SCREENING CIE KIT | ENA SCREENING CIE KIT |
| 20 | TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851 |
MULTIPLE | VARIOUS |
| 21 | ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901 |
ANA SCREEN ELISA TEST SYSTEM | ANA SCREEN ELISA TEST SYSTEM |
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