VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK MANUFACTURED BY ORTHO-CLINICAL DIAGNOSTICS

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VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK

Request for Information Form	Contact Information
Company Name	ORTHO-CLINICAL DIAGNOSTICS
Address	FOREST FARM ESTATE WHITCHURCH
City, State, Zip	CARDIFF,
Country	UK
FDA Owner/Operator Phone	585-453-4469
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CGR
FDA Classification Name	RADIOIMMUNOASSAY, CORTISOL
FDA Device Classification Code	Standards
FDA Regulation Number	862.1205
FDA Common Generic Name	CORTISOL ASSAY
FDA Proprietary Device Name	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK
FDA Owner / Operator Number	9011934
FDA Owner / Operator Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Establishment Registration Number	9680658
FDA Registered Establishment Name	ORTHO-CLINICAL DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	12-01-05
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

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	ADALTIS S.P.A. DIAGNOSTICS PLANT VIA LUIGI EINAUDI, 7 GUIDONIA MONTECELIO, ROMA, 00012 IT 514-335-9922 / 514-335-9922	CORTISOL MAIA RIA KIT (MULTIPLE BRANDS)	CORTISOL RADIOIMMUNOASSAY
2	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS CORTISOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	CORTISOL EIA (ENZYME IMMUNOASSAY)
3	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	VARIOUS
4	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	GAMMACOAT CORTISOL (125-I) RIA KIT	RIA KIT FOR DETERMINATION OF CORTISOL LEVELS
5	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	RADIOIMMUNOASSAY, CORTISOL	RADIOIMMUNOASSAY, CORTISOL
6	IBL GMBH FLUGHAFENSTRASSE, 52A HAMBURG, D-22335 GM 49-40-53289122 / 715-294-1752	IBL CORTISOL LUMINESCENCE IMMUNOASSAY	IBL CORTISOL LUMINESCENCE IMMUNOASSAY
7	IMMUNOSPEC CORPORATION 9428 ETON AVENUE, UNIT O CHATSWORTH, CA 91311 US 818-717-1840 / 818-717-1840	CORTISOL EIA	CORTISOL
8	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	CEDIA CORTISOL ASSAY	HOMEGENEOUS ENZYME IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF CORTISOL IN
9	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	CEDIA CORTISOL ASSAY	HOMOGENEOUS ENZYME IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF CORTISOL
10	MILENIA BIOTEC GMBH HOHESTRASSE 4-8 BAD NAUHEIM, 61231 GM 496-032-80400 / 603-893-8914	ALPCO MILENIA CORTISOL EIA	CORTISOL EIA
11	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	IMMUNCHEM CORTISOL COATED TUBE	IMMUNCHEM CORTISOL COATED TUBE
12	NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO SAN CLEMENTE, CA 92673 US 949-940-7200 / 949-940-7465	MULTIPLE	MULTIPLE
13	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS CORTISOL TEST SYSTEM	CORTISOL TEST SYSTEM
14	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	NO PROPRIETARY NAME LISTED	SAME
15	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 CORTISOL	IMMUNOASSAY FOR THE MEASUREMENT OF CORTISOL
16	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 CORTISOL	IMMUNOASSAY FOR THE MEASUREMENT OF CORTISOL
17	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS:180 CORTISOL	CORTISOL
18	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	DOUBLE ANTIBODY CORTISOL	IMMUNOASSAY FOR MEASUREMENT OF CORTISOL
19	UNITED BIOTECH, INC. 211 S. WHISMAN ROAD, SUITE E MOUNTAIN VIEW, CA 94041 US 650-961-2910 / 650-961-2910	UBI MAGIWEL (TM) CORTISOL QUANTITATIVE	CORTISOL