VITROS CHEMISTRY PRODUCTS FE SLIDES MANUFACTURED BY ORTHO-CLINICAL DIAGNOSTICS, INC.

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VITROS CHEMISTRY PRODUCTS FE SLIDES

Request for Information Form	Contact Information
Company Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
Address	300 WEILAND RD.
City, State, Zip	ROCHESTER, NY 14652
Country	US
FDA Owner/Operator Phone	585-453-4469
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JIY
FDA Classification Name	PHOTOMETRIC METHOD, IRON (NON-HEME)
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1410
FDA Common Generic Name	IRON (NON-HEME) TEST SYSTEM
FDA Proprietary Device Name	VITROS CHEMISTRY PRODUCTS FE SLIDES
FDA Owner / Operator Number	9011934
FDA Owner / Operator Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Establishment Registration Number	1319809
FDA Registered Establishment Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-28-96
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ORTHO-CLINICAL DIAGNOSTICS, INC.

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	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	IRON (NON-HEME) PHOTOMETRIC METHOD
2	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	IRON (NON-HEME) PHOTOMETRIC METHOD
3	CALDON BIOSCIENCE, INC. 2100 SOUTH RESERVOIR ST. POMONA, CA 91766 US 909-628-9944 / 909-628-9944	IRON REAGENT	IRON REAGENT
4	CALDON BIOTECH, INC. 2251 RUTHERFORD RD. CARLSBAD, CA 92008 US 760-804-7378 / 760-804-7378 305	IRON REAGENT	IRON REAGENT
5	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS IRON METHODS
6	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396	IRON ASSAY	IRON ASSAY
7	EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605	NO PROPRIETARY NAME LISTED	COLORIMETRIC IRON METHOD
8	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	NO PROPRIETARY NAME LISTED	PHOTOMETRIC METHOD, IRON
9	EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. EXTON, PA 19341 US 617-252-7500 / 617-768-6275	BIOTROL IRON	TOTAL IRON
10	GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 BREA, CA 92821 US 714-529-7125 / 714-529-7166	IRON	IRON REAGENT
11	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	IRON MULTIPLE DIAGNOSIS	IRON MULTIPLE DIAGNOSIS
12	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92	MULTIPLE	IRON
13	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688	OLYMPUS IRON REAGENT AND UNSATURATED IRON BINDING REAGENT	IRON REAGENT AND UNSATURATED IRON BINDING REAGENTS
14	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
15	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
16	SENTINEL CH. SPA VIA ROBERT KOCH, 2 MILANO, 20152 IT 39-02-3455141 / 978-927-3808	IRON LIQUID	PHOTOMETRIC METHOD, IRON (NON-HEME)
17	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
18	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772	STANBIO CAB:IRON LIQUICOLOR TEST SET	QUANTITATIVE COLORIMETRIC DETERMINATION OF TOTAL IRON IN SERUM
19	THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100	TRACE IRON (TUIBC) REAGENT	IRON REAGENT
20	VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553	MULTIPLE	VARIOUS TOTAL IRON REAGENTS
21	WIENER LABORATORIOS S.A.I.C. 2571 MAIPU ROSARIO SANTA FE, 2000 AR 011-543-414851982 / 011-543-414851982	FER-COLOR	PHOTOMETRIC METHOD FOR SERUM IRON AND TOTAL IRON BINDING CAPACITY DETERMINATION

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