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ANA DETECT
 Request for Information Form |
 Contact Information
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| Company Name | ORGENTEC DIAGNOSTIKA GMBH |
| Address | CARL-ZEISS-STRASSE 49 |
| City, State, Zip | MAINZ, |
| Country | GM |
| FDA Owner/Operator Phone | 011-49-613192580 |
| FDA Medical Specialty Code | IM - Immunology |
| FDA Product Code | LJM |
| FDA Classification Name | ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.5100 |
| FDA Common Generic Name | ANA SCREEN |
| FDA Proprietary Device Name | ANA DETECT |
| FDA Owner / Operator Number | 9022938 |
| FDA Owner / Operator Name | ORGENTEC DIAGNOSTIKA GMBH |
| FDA Establishment Registration Number | 3003232042 |
| FDA Registered Establishment Name | ORGENTEC DIAGNOSTIKA GMBH |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 02-12-04 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ORGENTEC DIAGNOSTIKA GMBH
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 | AMICO LAB, INC. 5012 ILLINOIS AVE. P.O. BOX 90203 NASHVILLE, TN 37209 US 615-385-7711 / 615-385-7711 |
1FA AN DNA TEST KIT, ELISA AN DNA TEST KIT | 1FA AN DNA TEST KIT, ELISA AN DNA TEST KIT |
| 3 | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263 |
MULTIPLE | VARIOUS |
| 4 | CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130 |
MULTIPLE | CENP-B, ANA |
| 5 | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US 305-324-2300 / 305-324-2354 |
ANTI-SM MICROASSAY | ANTI-SM EIA |
| 6 | EURO-DIAGNOSTICA AB MEDEON MALMO, S-205 12 SW / +46-40-32 11 00 |
DIASTAT ANTI HISTONE TEST SYSTEM | ELISA FOR THE DETECTION OF AUTOANTIBODIES TO HISTONE |
| 7 | GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309 |
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 1 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 1 |
| 8 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
ANA SCREEN MULTIPLE DIAGNOSIS PRODUCTS | ANA SCREEN MULTIPLE DIAGNOSIS PRODUCTS |
| 9 | HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111 |
AUTOSTAT II ANA SCREEN ELISA | AUTOSTAT II ANA SCREEN ELISA |
| 10 | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US 716-691-0091 / 716-691-0091 |
IMMCO DIAGNOSTICS IMMULISA ANTI HISTONE ANTIBODY ASSAY | ANTI HISTONE ANTIBODY ELISA |
| 11 | IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D SACRAMENTO, CA 95827 US 916-363-2649 / 916-363-2649 |
RELISA (R) ANA SCREENING TEST SYSTEM | RELISA (R) ANA SCREENING TEST SYSTEM |
| 12 | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131 US 858-586-9900 / 858-586-9900 351 |
QUANTA LITE | SSDNA ELISA KIT |
| 13 | MBL INTERNATIONAL CORP. 15 B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964 |
RHIGENE MESACUP-2 TEST - SCI-70 | SCI-70 ELISA KIT |
| 14 | MBL INTERNATIONAL CORPORATION 15B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964 |
MESACUP ANA TEST | ANA ELISA KIT |
| 15 | MEDICAL & BIOLOGICAL LABORATORIES CO. LTD., INA LA 1063-103 OHARA TERASAWAOKA INA, NAGANO, 396-0002 JA 052-971-2081 / 81-265-761777 |
ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS~IMMUNOLOGY | ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS~IMMUNOLOGY |
| 16 | MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 TUSTIN, CA 92780 US 714-832-8234 / 714-832-8234 |
MDISCL-70 TEST | ELISA TEST SEROLOGY |
| 17 | NOVAMED LTD. 28 PIERRE KOENIG ST., TALPIOT INDUSTRIAL AREA JERUSALEM, 93469 IS 972-267-81861 / 972-267-1861X111 |
AUTOIMMUNE ELISA ASSAYS | ENZYMEIMMUNOASSAYS KITS FOR DETECTION OF AUTOIMMUNE ANTIBODIES |
| 18 | PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278 |
MULTIPLE | VARIOUS ANTINUCLEAR ANTIBODY ASSAYS |
| 19 | QUEST INTL., INC. 1938 N.E. 148TH TERR. NORTH MIAMI, FL 33181 US 305-948-8788 / 305-948-8788 |
SERAQUEST ANTI-SSA | ANTI-SSA SEROLOGICAL REAGENTS, ELISA |
| 20 | QUIDEL CORP. 2981 COPPER RD. SANTA CLARA, CA 95051 US 858-552-1100 / 858-552-1100 7910 |
MULTIPLE | ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL |
| 21 | THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000 |
BIRDAZYME ANA SCREEN ENZYME IMMUNOASSAY KIT | ANA SCREEN EIA KIT |
| 22 | TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851 |
MULTIPLE | VARIOUS TYPES OF ANTINUCLEAR ANTIBODY ELISA TEST KITS |
| 23 | TRIPATH IMAGING, INC. 780 PLANTATION DR. BURLINGTON, NC 27215 US 201-847-6800 / 919-206-7140 |
ANTI-NUCLEAR ANTIBODY SYSTEM | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL TEST SYSTEM |
| 24 | UNITED BIOTECH, INC. 211 S. WHISMAN ROAD, SUITE E MOUNTAIN VIEW, CA 94041 US 650-961-2910 / 650-961-2910 |
UBI MAGIWEL (TM) ANA QUANTITATIVE | ANTINUCLEAR ANTIBODY ENZYME-LABELED (ANA) |
| 25 | ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901 |
ZEUS DSDNA ELISA TEST SYSTEM | DSDNA ELISA TEST SYSTEM |
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