TINA-QUANT A C3 MANUFACTURED BY ROCHE DIAGNOSTICS GMBH

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TINA-QUANT A C3

Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS GMBH
Address	SANDHOFER STRASSE 116
City, State, Zip	MANNHEIM,
Country	GM
FDA Owner/Operator Phone	49-621-7670
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	CZW
FDA Classification Name	COMPLEMENT C3, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5240
FDA Common Generic Name	TINA-QUANT A C3 FOR HITACHI
FDA Proprietary Device Name	TINA-QUANT A C3
FDA Owner / Operator Number	9039767
FDA Owner / Operator Name	CORANGE DEUTSCHLAND HOLDING GMBH
FDA Establishment Registration Number	9610126
FDA Registered Establishment Name	ROCHE DIAGNOSTICS GMBH
FDA Operation Code(s)	AA - Initial Distributor
FDA Listing Date
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	ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	C3	COMPLEMENT 3
2	AMICO LAB, INC. 5012 ILLINOIS AVE. P.O. BOX 90203 NASHVILLE, TN 37209 US 615-385-7711 / 615-385-7711	GOAT ANTI-HUMAN C3 ANTISERUM	I FA C3
3	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	C3
4	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	C3
5	CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272	C3	COMPLEMENT C3 REAGENT
6	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS
7	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	DIMENSION C3 METHOD	DIMENSION C3 METHOD
8	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	MULTIPLE	VARIOUS
9	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	EZ COMPLEMENT C3 MULTIPLE DIAGNOSIS PRODUCTS	EZ COMPLEMENT C3 MULTIPLE DIAGNOSIS PRODUCTS
10	IBL GMBH FLUGHAFENSTRASSE, 52A HAMBURG, D-22335 GM 49-40-53289122 / 715-294-1752	IBL C3D-CIC EIA TEST	COMPLEMENT C3, ANTIGEN, ANTISERUM, CONTROL IMMUNOLOGY
11	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068	K-ASSAY C3 IMMUNOTURBIDIMETRIC ASSAY	C3 IMMUNOTURBIDIMETRIC ASSAY
12	KENT LABORATORIES, INC. 777 JORGENSEN PLACE BELLINGHAM, WA 98226 US 360-398-8641 / 360-398-8641	C-3 (B1C/B1A) ANTISERUM	C-3 (B1C/B1A) ANTISERUM
13	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 C3-S	COMPLEMENT C3 ITA
14	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688	OLYMPUS C3 REAGENT	C3 REAGENT
15	ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	VITROS CHEMISTRY PRODUCTS C3 REAGENT	COMPLEMENT C3 ASSAY
16	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	POLYMEDCO POLY-CHEM SYSTEM COMPLEMENT C3	COMPLEMENT C3
17	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX COMPLEMENT C3	COMPLEMENT C3
18	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX COMPLEMENT C3	COMPLEMENT C3
19	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX COMPLEMENT C3	COMPLEMENT C3
20	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX COMPLEMENT C3	COMPLEMENT C3
21	REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501	RAICHEM;SPIA;C3 REAGENT	REAGENT FOR TURBIDIMETRIC IMMUNOASSAY OF C3
22	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
23	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	C3 MININEPH ANTISERUM	C3 MININEPH KIT
24	THE BINDING SITE, INC. 5889 OBERLIN DR., SUITE 101 SAN DIEGO, CA 92121 US 858-453-9177 / 858-453-9177		IMMUNOLOGICAL TEST SYSTEM

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