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EUROIMMUN PR3-MPO ELISA KIT
 Request for Information Form |
 Contact Information
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| Company Name | EUROIMMUN US LLC |
| Address | 429 ROCKAWAY VALLEY RD.
UNIT 1200 |
| City, State, Zip | BOONTON, NJ 07005 |
| Country | US |
| FDA Owner/Operator Phone | 973-402-6101 |
| FDA Medical Specialty Code | IM - Immunology |
| FDA Product Code | MOB |
| FDA Classification Name | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA) |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 866.5660 |
| FDA Common Generic Name | PR3-MPO ELISA KIT |
| FDA Proprietary Device Name | EUROIMMUN PR3-MPO ELISA KIT |
| FDA Owner / Operator Number | 9066845 |
| FDA Owner / Operator Name | EUROIMMUN US LLC |
| FDA Establishment Registration Number | 3004754465 |
| FDA Registered Establishment Name | EUROIMMUN US LLC |
| FDA Operation Code(s) |
MS - Specification Developer |
| FDA Listing Date | 12-21-06 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of EUROIMMUN US LLC
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 | BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG MARNE LA VALLEE CEDEX 2, 77435 FR 33-164-621012 / 33-166-621012 |
IMMUNOGICAL TEST SYSTEM FOR FIDIS TM VASCULITIS | FIDIS TM VASCULITIS |
| 2 | CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130 |
MULTIPLE | MPO ANCA, PR3 ANCA |
| 3 | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US 305-324-2300 / 305-324-2354 |
IS- ANTI PR3. | ANTI-PROTEMAX -3 ANTIBODY ELISA |
| 4 | EURO-DIAGNOSTICA AB MEDEON MALMO, S-205 12 SW / +46-40-32 11 00 |
MULTIPLE | VARIOUS |
| 5 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
ANCA COMBI DIAGNOSTIC TEST MULTIPLE DIAGNOSIS PRODUCTS | ANCA COMBI DIAGNOSTIC TEST MULTIPLE DIAGNOSIS PRODUCTS |
| 6 | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501 |
VIRGO | IFA |
| 7 | HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111 |
MULTIPLE | VARIOUS |
| 8 | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US 716-691-0091 / 716-691-0091 |
IMMCO DIAGNOSTICS IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY ASSAY | ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY ANCA IFA |
| 9 | IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D SACRAMENTO, CA 95827 US 916-363-2649 / 916-363-2649 |
IMMUNO CONCEPTS RELISA (R) PR3-ANCA TEST SYSTEM FOR ANITBODIES TO PROTEINASE 3 | RELISA (R) PR3-ANCA TEST SYSTEM |
| 10 | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131 US 858-586-9900 / 858-586-9900 351 |
MULTIPLE | VARIOUS |
| 11 | MBL INTERNATIONAL CORP. 15 B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964 |
MESACUP MPO TEST | MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM |
| 12 | MBL INTERNATIONAL CORPORATION 15B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964 |
MESACUP ANCA TEST | MULTIPLE ANTI-MPO AND ANTI-PR3 |
| 13 | MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285 |
MOP ELISA, PR3 ELISA | ANCA, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES |
| 14 | ORGENTEC DIAGNOSTIKA GMBH CARL-ZEISS-STRASSE 49 MAINZ, 55129 GM 011-49-613192580 / 763-780-2955 |
ORGENTEC ANTI MPO ASSAY | ANTI MPO ASSAY |
| 15 | PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278 |
MULTIPLE | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA) |
| 16 | PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND ROENTGENSTRASSE 24 HAMBURG, D-22335 GM 425-487-7000 / 978-659-4663 |
SOLID STATE X-RAY IMAGER | FLAT PANEL DETECTOR/DIGITAL DECTECTOR |
| 17 | THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000 |
ANCA COMBI KIT WITH IF AIM | ANCA COMBI KIT WITH IF AIM |
| 18 | THERATEST LABORATORIES, INC. 1111 N. MAIN ST. LOMBARD, IL 60148 US 630-627-6069 / 630-627-6069 |
EL-ANCA,ANTI-PR3, ANTI-MPO | ANTI-PROTEINASE 3 AND ANTI-MYELOPEROXIDASE ANTIBODIES |
| 19 | TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851 |
MULTIPLE | VARIOUS TYPES OF ANCA ELISA TEST KITS |
| 20 | ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901 |
ATHENA MULTI-LYTE(R) ANCA TEST SYSTEM | ANCA TEST SYSTEM |
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