IRON AND IRON BINDING CAPACITY MANUFACTURED BY ROCHE DIAGNOSTICS CORP.

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IRON AND IRON BINDING CAPACITY

Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS CORP.
Address	9115 HAGUE RD.
City, State, Zip	INDIANAPOLIS, IN 46250
Country	US
FDA Owner/Operator Phone	--
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JMO
FDA Classification Name	FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1415
FDA Common Generic Name	IRON AND IRON BINDING CAPACITY
FDA Proprietary Device Name	IRON AND IRON BINDING CAPACITY
FDA Owner / Operator Number	1823260
FDA Owner / Operator Name	ROCHE HOLDING, INC.
FDA Establishment Registration Number	1823260
FDA Registered Establishment Name	ROCHE DIAGNOSTICS CORP.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-08-97
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 CORP.

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	MULTIPLE	IRON BINDING CAPACITY ASSAYS
2	AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 SOLON, OH 44139 US 440-349-1199 / 440-914-3409	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
3	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	LIQUID - STAT IRON/BC REAGENT	IRON BINDING CAPACITY ANALYSIS PRODUCT
4	BENCHMARK REAGENTS P.O. BOX 474 HORSHAM VICT 3400, AS / 53--8462850	ALFERR TIBC TUBE	TOTAL IRON BINDING CAPACITY (ALUMINA ADSORBENT)
5	BIO PHASE DIAGNOSTICS LABORATORY 6625 KITIMAT RD., UNIT #51 MISSISSAUGA, ONTARIO, L5N 6J1 CA 905-567-9165 / 905-567-9165	IRON BINDING CAPACITY	FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
6	CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272	UIBC	UNSATURATED IRON BINDING CAPACITY REAGENT
7	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS IRON
8	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396	IRON/UIBC ASSAYS	IRON/UIBC ASSAYS
9	EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605	NO PROPRIETARY NAME LISTED	FERROZINE IRON BINDING METHOD
10	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	TIBC SET	TIBC SET
11	EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. EXTON, PA 19341 US 617-252-7500 / 617-768-6275	BIOTROL UIBC	UNSATURATED IRON BINDING CAPACITY
12	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY	FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
13	INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061	IRON TIBC AND IRON TOTAL	IRON TIBC AND IRON TOTAL
14	JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320	IRON (UIBC)	IRON (UIBC)
15	KING DIAGNOSTICS, INC. 980 PARK CTR. DR. SUITE F,G VISTA, CA 92081 US 760-597-1182 / 760-597-1182	IRON	IRON
16	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688	UNSATURATED IRON BINDING CAPACITY REAGENT	UNSATURATED IRON BINDING CAPACITY REAGENT
17	ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	MULTIPLE	IRON-BINDING CAPACITY TEST SYSTEM
18	POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US 734-487-8300 / 734-487-8310		IRON/TIBC AND IRON(TOTAL)
19	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	POLYMEDCO POLY-CHEM SYSTEM, DIRECT TOTAL IRON BINDING CAPACITY (TIBC)	DIRECT TOTAL IRON BINDING CAPACITY, DTIBC, TOTAL IRON BINDING CAPACITY, TIBC
20	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX IRON	IRON
21	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX IRON	IRON
22	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX IRON	IRON
23	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX IRON	IRON
24	REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501	RAICHEM	REAGENT FOR DETERMINATION OF IRON AND IRON BINDING CAPACITY IN SERUM
25	REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 BEDFORD, MA 01730 US 781-276-9000 / 781-276-9000	DIRECT TOTAL IRON-BINDING CAPACITY KIT	DIRECT TIBC KIT
26	SANDARE INTL., INC. 910 K.C.K. WAY CEDAR HILL, TX 75104 US 972-293-7440 / 972-293-7440	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
27	SHARED SYSTEMS, INC. 3961 COLUMBIA RD. MARTINEZ, GA 30907 US 706-868-0408 / 706-868-0408	DIRECT TOTAL IRON-BINDING CAPACITY KIT	IRON BINDING CAPACITY, TOTAL
28	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	ADVIA 1650 IRON ASSAY	IRON ASSAY
29	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772	IRON AND TOTAL IRON-BINDING CAPACITY TEST SET, CAT. NO. 0370	QUANTITATIVE COLORIMETRIC DETERMINATION OF IRON & UNSATURATED IRON-BINDING
30	STERLING DIAGNOSTICS, INC. 36645 METRO COURT STERLING HEIGHTS, MI 48312 US 810-979-9171 / 810-979-2141		FERROZINE COLORIMETRIC IRON AND IRON BINDING REAGENT SET
31	SYNERMED INTL., INC. 17408 TILLER COURT, STE. 1900 WESTFIELD, IN 46074 US 317-896-1565 / 317-896-1565	SYNERMED UIBC REAGENT KIT	UIBC REAGENT KIT
32	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788		IRON/TOTAL IRON BINDING CAPACITY (IRON/TIBC)
33	THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100	IRON REAGENT/UIBC REAGENT FERENE METHOD, UIBC REAGENT	IRON-BINDING CAPACITY TEST SYSTEM
34	VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553	ATAC TIBC COLUMN KIT	IRON BINDING CAPACITY SAMPLE PRETREATMENT KIT
35	WIENER LABORATORIOS S.A.I.C. 2571 MAIPU ROSARIO SANTA FE, 2000 AR 011-543-414851982 / 011-543-414851982	FER COLOR TRANSFERINA	PHOTOMETRIC METHOD FOR IRON BINDING CAPACITY DETERMINATION