SOLID STATE X-RAY IMAGER MANUFACTURED BY PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND

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SOLID STATE X-RAY IMAGER

Request for Information Form	Contact Information
Company Name	PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
Address	ROENTGENSTRASSE 24
City, State, Zip	HAMBURG,
Country	GM
FDA Owner/Operator Phone	425-487-7000
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	FLAT PANEL DETECTOR/DIGITAL DECTECTOR
FDA Proprietary Device Name	SOLID STATE X-RAY IMAGER
FDA Owner / Operator Number	1217116
FDA Owner / Operator Name	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
FDA Establishment Registration Number	3003768251
FDA Registered Establishment Name	PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-29-01
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of PHILIPS MEDICAL SYSTEMS GMBH DMC, DEVELOPMENT AND

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	EUROIMMUN US LLC 429 ROCKAWAY VALLEY RD. UNIT 1200 BOONTON, NJ 07005 US 973-402-6101 / 973-402-6101	EUROIMMUN PR3-MPO ELISA KIT	PR3-MPO ELISA KIT
6	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
7	HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501	VIRGO	IFA
8	HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111	MULTIPLE	VARIOUS
9	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
10	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
11	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131 US 858-586-9900 / 858-586-9900 351	MULTIPLE	VARIOUS
12	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
13	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
14	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
15	ORGENTEC DIAGNOSTIKA GMBH CARL-ZEISS-STRASSE 49 MAINZ, 55129 GM 011-49-613192580 / 763-780-2955	ORGENTEC ANTI MPO ASSAY	ANTI MPO ASSAY
16	PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278	MULTIPLE	TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)
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