ELECSYS ANALYZER 1010, ELECSYS ANALYZER 2010 MANUFACTURED BY ROCHE DIAGNOSTICS GMBH

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ELECSYS ANALYZER 1010, ELECSYS ANALYZER 2010

Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS GMBH
Address	NONNENWALD 2
City, State, Zip	PENZBERG,
Country	GM
FDA Owner/Operator Phone	49-621-7670
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	KQO
FDA Classification Name	AUTOMATED URINALYSIS SYSTEM
FDA Device Classification Code	General Controls
FDA Regulation Number	862.2900
FDA Common Generic Name	ELECSYS 1010, ELECSYS 2010
FDA Proprietary Device Name	ELECSYS ANALYZER 1010, ELECSYS ANALYZER 2010
FDA Owner / Operator Number	9036646
FDA Owner / Operator Name	ROCHE DIAGNOSTICS GMBH MANNHEIM
FDA Establishment Registration Number	9610529
FDA Registered Establishment Name	ROCHE DIAGNOSTICS GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-07-01
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ROCHE DIAGNOSTICS 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	ANALYTICON BIOTECHNOLOGIES AG AM MUEHLENBERG 10 LICHTENFELS, 35104 GM 49-645-4 7991 0 / 847-374-8854	COMBI SCAN	AUTOMATED URINALYSIS SYSTEM
2	ARKRAY FACTORY INC. 1480 KOJI,KONAN-CHO, KOKA-SHI SHIGA,, 520-3306 JA 81-75-6628964 / 81-748-867298	AUTION MAX AX-4280 URINALYSIS SYSTEM	URINALYSIS SYSTEM
3	ARKRAY FACTORY SHANGHAI, INC. NO. 72-1, 887 ZUCHONGZHI RD., ZHANGJIANG HIGH-TECH PARK, PUDONG, SHANGHAI, 201203 CH 81-75-6628964 / 81-748-867298	AUTION MAX AX-4280 URINALYSIS SYSTEM	URINALYSIS SYSTEM
4	ARKRAY FACTORY USA, INC. 5182 WEST 76TH ST. MINNEAPOLIS, MN 55439 US 81-75-6628964 / 952-646-3168	DIASCREEN 50 URINE CHEMISTRY ANALYZER	URINE CHEMISTRY ANALYZER
5	ARKRAY, INC. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO, 601-8045 JA 81-75-6628964 / 81-748-867298	AUTION MAX AX-4280 URINALYSIS SYSTEM	URINALYSIS SYSTEM
6	BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. 5TH FLOOR TARRYTOWN, NY 10591 US 914-524-2955 / 574-262-6372	CLINILAB AUTOMATED URINALYSIS SYSTEM	AUTOMATED URINALYSIS SYSTEM
7	BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. MISHAWAKA, IN 46544 US 914-524-2955 / 574-256-3430	CLINILAB AUTOMATED URINALYSIS SYSTEM	AUTOMATED URINALYSIS SYSTEM
8	BERKLEY INDUSTRIES, LLC 14450 INDUSTRY CIR. LA MIRADA, CA 90638 US 714-670-4274 / 714-522-5400 4274	URINQUICK	URINALYSIS INSTRUMENT
9	BIOCARE CORP. 2F. NO. 25 R&D RD. II SCIENCE-BASED INDUSTRIAL PARK HSINCHU, 300 TW 886-357-81410x6222 / 886-357-81410x6222	STRIPMAX 1210	URINE CHEMISTRY ANALYZER
10	CJS INTERNATIONAL CO., INC. SANGAEDONG 1265 MIJU APT 105-1102 NOWONGU, SEOUL, KS 82-2-62232979 / 301-801-9083	URILAB-700	AUTOMATED URINALYSIS SYSTEM
11	DIRUI INDUSTRIAL CO., LTD. 95 YUNHE ST., NEW & HIGH TECH DEVELOPMENT ZONE CHANGCHUN, 130012 CH 86-431-5100409 / 516-482-9001	DIRUI	URINE ANALYZER
12	HEMOCUE AB KUVETTGATAN 1 ANGELHOLM, SE-262 71 SW 464-314-5 82 00 / 800-881-1611 110	HEMOCUE URINE ALBUMIN SYSTEM	URINE ALBUMIN SYSTEM
13	HITACHI HIGH-TECH SCIENCE SYSTEMS CORPORATION 1040 ICHIGE HITACHINAKA-SHI, JA 81-335-045836 / 81-29-3544029	BM/HITACHI CHEMISTRIP SUPPER UA	AUTOMATED URINE CHEMISTY ANALYZER
14	IND DIAGNOSTIC INC. 1629 FOSTERS WAY DELTA, BC, V3M 6S7 CA 604-522-1619 / 604-522-1619	URINE CHEMISTRY ANALYZER	AUTOMATED URINALYSIS READER
15	IRIS DIAGNOSTICS 9172 ETON AVE. CHATSWORTH, CA 91311 US 818-709-1244 7129 / 818-709-1244 7129	THE YELLOW IRIS	AUTOMATED URINALYSIS WORKSTATION
16	IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 331 SOUTH 104TH ST. LOUISVILLE, CO 80027 US 781-674-3900 / 303-530-6612	POCKET CHEM UA	URINALYSIS INSTRUMENT
17	KIMBALL ELECTRONICS (WALES) LIMITED WESTERN AVENUE BRIDGEND INDUSTRIAL ESTATE BRIDGEND, WALES, CF31 3TY UK 812-634-4172 / 44-163-5566448	CLINITEK 500 URINE CHEMISTRY ANALYZER & ACCESSORIES	AUTOMATED URINALYSIS INSTRUMENT
18	MEDITEC CO. #202 2F, SAMIK BUILDING, 609-2 KONGRUNG DONG SEOUL, KS 82-2-3296-2008 / 714-693-7788	URITEK-720+URINE ANALYZER	URINE READER
19	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	MULTIPLE	AUTOMATED URINALYSIS SYSTEM
20	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	MULTIPLE	AUTOMATED URINALYSIS SYSTEM
21	ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. BETHLEHEM, PA 18018 US 610-882-1820 / 610-882-1820 5043	AUTOMATED URINALYSIS SYSTEM (MULTIPLE BRANDS)	VARIOUS TYPES OF AUTOMATED URINALYSIS SYSTEMS
22	PRIMUS CORP. 4231 E. 75TH TERRACE KANSAS CITY, MO 64132 US 353-127-69800 / 816-523-7491	GLYCATED CONTROL	GHB CONTROL (LYOPHILIZED OR LIQUID) GPP CONTROL (LYOPHILIZED)
23	ROCHE DIAGNOSTICS GMBH FRIEDRICH-EBERT-STRABE 100 MANNHEIM, 68167 GM 49-621-7670 / 317-521-2834	CHEMSTRIP CRITERION, SUPER UA	AUTOMATED URINALYSIS SYSTEM
24	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	UROTRON	AUTOMATED URINE TEST STRIP SCANNER
25	SEAN BIO CO., LTD. 715-1 CHORANG 3 DONG DONGU, BUSAN, 601-827 KS 82-51-4634046 / 301-801-9083	URIAN 501/URIAN 1001	URIAN 501/URIAN 1001
26	SEAN IMAGINATION TECHNOLOGY CO. LTD. 715-1 CHORANG 3 DONG, DONG GU BUSAN, KS 011-82-514634046 / 703-506-8787	UA 1001/UA 501 (OR UA 1001/UA 501 SEMI-AUTOMATED URINALYSIS)	UA 1001/UA 501 (OR UA 1001/UA 501 SEMI-AUTOMATED URINALYSIS)
27	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 3400 MIDDLEBURY ST. ELKHART, IN 46514 US 914-524-2955 / 914-524-2955	CLINILAB AUTOMATED URINALYSIS SYSTEM	AUTOMATED URINALYSIS SYSTEM
28	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MFG LTD CHAPEL LANE SWORDS, COUNTY DUBLIN, EI 914-524-2955 / 914-524-2955	CLINITEK 500 URINE CHEMISTRY ANALYZER & ACCESSORIES	AUTOMATED URINALYSIS INSTRUMENT
29	SPARTON MEDICAL SYSTEMS 22740 LUNN RD. STRONGSVILLE, OH 44149 US 800-248-9579 / 440-878-4630 226	CLINITEK ATLAS URINE CHEMISTRY ANALYZER	AUTOMATED URINALYSIS SYSTEM
30	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772	URI-TRAK 100	AUTOMATED URINALYSIS SYSTEM
31	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788	URITEK-720+URINE STRIP READER, URITEK-151 URINE STRIP READER	URINE STRIP READER
32	YD DIAGNOSTICS 173 SEO-RI, YIDONG-MYUN YONGIN KYUNGGI-DO SEOUL, 449-834 KS / 822-223-33531	"MULTIPLE" URISCAN PRO AND URISCAN OPTIMA	VARIOUS MODELS OF URINE CHEMISTRY ANALYZER (URINALYSIS SYSTEM)