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QUANTA LITE
 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 | DHR |
| FDA Classification Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.5775 |
| FDA Common Generic Name | RF IGM TEST KIT |
| 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 | ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471 |
RF | RHEUMATOID FACTOR |
| 2 | AKERS BIOSCIENCES, INC. 201 GROVE RD. THOROFARE, NJ 08086 US 856-848-8698 / 856-848-8698 |
HEALTHTEST RHEUMATOID FACTOR ASSAY | LATEX AGGLUTINATION ASSAY FOR RHEUMATOID ARTHRITIS FACTORS |
| 3 | AMERITEK USA, INC. 125 130 ST. SE, #200 EVERETT, WA 98208 US 425-379-2580 / 425-379-2580 |
DBEST RF TEST KIT | RF TEST KIT |
| 4 | ARLINGTON SCIENTIFIC, INC. 1840 NORTH TECHNOLOGY DR. SPRINGVILLE, UT 84663 US 801-489-8911 / 801-489-8911 |
MULTIPLE | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
| 5 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | RF |
| 6 | BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383 |
MULTIPLE | RF |
| 7 | BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000 |
NO PROPRIETARY NAME LISTED | RF LATEX AGGLUTINATION TEST |
| 8 | BIO-MEDICAL PRODUCTS CORP. 10 HALSTEAD RD. MENDHAM, NJ 07945 US 973-543-7434 / 973-543-7434 |
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| 9 | BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. IRVINE, CA 92618 US 510-724-7000 / 949-598-1200 |
LIQUICHEK RHEUMATOID FACTOR | LIQUICHEK RHEUMATOID FACTOR |
| 10 | CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272 |
RF | RHEUMATOID FACTOR REAGENT |
| 11 | CENOGENICS CORP. 100 RT. 520 MORGANVILLE, NJ 07751 US 732-536-6457 / 732-536-6457 |
RF LATEX | RF LATEX |
| 12 | CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130 |
RHEUMATOID FACTOR TEST KIT | REAADS RF SEMI-QUANTITATIVE TEST KIT |
| 13 | DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311 |
MULTIPLE | VARIOUS |
| 14 | DEXALL BIOMEDICAL LABS, INC. 18904 BONANZA WAY GAITHERSBURG, MD 20879 US / 301-840-1884 |
IMMUNDEX, ACTI.TIP | ENZYME IMMUNOASSAY TO DETECT/MEASURE RHEUMATOID FACTOR |
| 15 | DIAGNOSTIC TECHNOLOGY, INC. 175 COMMERCE DR. UNIT L HAUPPAUGE, NY 11788 US 631-582-4949 / 631-582-4949 |
RA-CHECK TM | LATEX SLIDE TEST FOR RHEUMATOID FACTORS |
| 16 | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US 305-324-2300 / 305-324-2354 |
RF MICROASSAY | RF EIA |
| 17 | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820 |
EL-RF | ENZYME IMMUNOASSAY FOR RHEUMATOID FACTOR |
| 18 | DOMINION BIOLOGICALS LTD. 5 ISNOR DR. DARTMOUTH, NOVA SCOTIA, B3B 1M1 CA 770-441-2051 / 770-441-2051 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 19 | EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315 |
RF TEST | RF TEST |
| 20 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
GLOBALEMED RF LATEX TEST | RHEUMATOID FACTOR (RF) LATEX TEST |
| 21 | HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111 |
AUTOSTAT TM II RHEUMATOID FACTOR IGM ELISA | AUTOSTAT TM II RF IGM ELISA |
| 22 | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US 716-691-0091 / 716-691-0091 |
IMMCO DIAGNOSTICS IMMULISA RHEUMATOID RF IGM ANTIBODY ASSAY | RHEUMATOID FACTOR RF IGM ANTIBODY ASSAY |
| 23 | IMMUNOSPEC CORPORATION 9428 ETON AVENUE, UNIT O CHATSWORTH, CA 91311 US 818-717-1840 / 818-717-1840 |
RF IGM EIA | RF IGM |
| 24 | IMMUNOSTICS, INC. 3505 SUNSET AVE. OCEAN, NJ 07712 US / 732-918-0770 |
IMMUNO/RA | LATEX SLIDE TEST FOR DETECTION OF INFLAMMATORY PROCESS |
| 25 | JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320 |
K-ASSAY RHEUMATOID | RHEUMATIID FACTOR (RF) |
| 26 | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068 |
MULTIPLE | RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC ASSAY AND CALIBRATORS |
| 27 | MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 TUSTIN, CA 92780 US 714-832-8234 / 714-832-8234 |
ELISA TEST SEROLOGY | MDI-RF-TEST |
| 28 | MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285 |
RHEUMATOID FACTOR ELISA | RHEUMATOID FACTOR ELISA |
| 29 | NERL DIAGNOSTICS LLC. 14 ALMEIDA AVE. EAST PROVIDENCE, RI 02914 US 412-490-8425 / 412-490-8425 |
ACCUTEX RF LATEX KITS | RF LATEX KITS |
| 30 | NITTO BOSEKI CO., LTD. (MEDICAL DIVISION) 4-1-28 KUDAN-KITA CHIYODA-KU TOKYO, 102-0073 JA 81-3-32384540 / 206-575-8068 |
N-ASSAY TIA RF | RHEUMATOID FACTOR ITA |
| 31 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688 |
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT | RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC |
| 32 | ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768 |
VITROS CHEMISTRY PRODUCTS RF REAGENT | RHEUMATOID FACTOR ASSAY |
| 33 | PRECISA INTL. CORP. 4890 S.W. 74TH CT. MIAMI, FL 33155 US 305-669-0895 / 305-669-0898 |
IMMUNO-RA | KIT FOR THE DETECTION OF RHEUMATOID ARTHRITIS |
| 34 | PULSE SCIENTIFIC, INC. 5100 SOUTH SERVICE RD., UNIT 18 BURLINGTON, ONTARIO, L7L 6A5 CA 905-333-8188 / 800-363-7907 |
PULSE RF TEST | RF (RA) TEST |
| 35 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
RANDOX RHEUMATOID FACTOR LATEX SLIDE TEST | RHEUMATOID FACTOR |
| 36 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
RANDOX RHEUMATOID FACTOR, LATEX SLIDE TEST | RHEUMATOID FACTOR |
| 37 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
RANDOX RHEUMATOID FACTOR, LATEX SLIDE TEST | RHEUMATOID FACTOR |
| 38 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
RANDOX RHEUMATOID FACTOR, LATEX SLIDE TEST | RHEUMATOID FACTOR |
| 39 | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501 |
RHEUMATOID FACTOR KIT | RF (RHEUMATOID FACTOR) |
| 40 | REMEL, INC. 12076 SANTA FE DR. LENEXA, KS 66215 US 412-490-8425 / 412-490-8425 |
MULTIPLE | RH FACTOR TEST SYSTEM |
| 41 | ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834 |
TINA-QUANT RHEUMATOID FACTOR ASSAY | IMMUNOTURBIDOMETRIC ASSAY FOR THE DETERMINATION OF RHEUMATOID FACTOR |
| 42 | SA SCIENTIFIC, INC. 4919 GOLDEN QUAIL SAN ANTONIO, TX 78240 US 210-699-8800 / 210-699-8800 202 |
SAS RF-LATEX | RHEUMATOID FACTOR TEST, LATEX |
| 43 | SCIMEDX CORP. 400 FORD RD. DENVILLE, NJ 07834 US 973-625-8822 20 / 201-625-8822 |
SYSTEM, TEST, RHEUMATOID FACTOR | SYSTEM, TEST, RHEUMATOID FACTOR |
| 44 | SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425 |
MULTIPLE | RH FACTOR TEST SYSTEM |
| 45 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
MULTIPLE | MULTIPLE |
| 46 | ST. PAUL BIOTECH 11555 MONARCH ST. GARDEN GROVE, CA 92841 US 714-903-1000 / 714-903-1000 226 |
MULTIPLE | RHEUMATOID FACTOR TEST |
| 47 | STERLING DIAGNOSTICS, INC. 36645 METRO COURT STERLING HEIGHTS, MI 48312 US 810-979-9171 / 810-979-2141 |
RHEUMATOID FACTOR(RF) REAGENT SET | |
| 48 | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788 |
RHEUMATOID FACTOR (RF) REAGENT: A LATEX SLIDE TEST | RHEUMATOID FACTOR (RF) REAGENT: A LATEX SLIDE TEST |
| 49 | TEXAS IMMUNOLOGY, INC. 12524 FM 3226 TYLER, TX 75707 US 903-566-6696 / 903-566-6696 |
V-TREND TARGET RF TEST, SERO/TEX RF TEST, SERO/TEX RED CELL RF TEST | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
| 50 | THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000 |
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
| 51 | THERATEST LABORATORIES, INC. 1111 N. MAIN ST. LOMBARD, IL 60148 US 630-627-6069 / 630-627-6069 |
EL-RF | ENZYME IMMUNOASSAY FOR RHEUMATOID FACTOR |
| 52 | TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851 |
MULTIPLE | RHEUMATOID FACTOR ELISA TEST SYSTEM |
| 53 | UNITED BIOTECH, INC. 211 S. WHISMAN ROAD, SUITE E MOUNTAIN VIEW, CA 94041 US 650-961-2910 / 650-961-2910 |
UBI MAGIWEL (TM) RF-IGM QUANTITATIVE | RF IGM,TEST RHEUMATOID FACTOR |
| 54 | ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901 |
ATHENA MULTI-LYTE(R) RF IGM TEST SYSTEM | RF IGM TEST SYSTEM |
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