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

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VITROS IMMUNODIAGNOSTIC PRODUCTS AFP 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	IM - Immunology
FDA Product Code	LOJ
FDA Classification Name	KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
FDA Device Classification Code	Standards
FDA Regulation Number	866.6010
FDA Common Generic Name	AFP ASSAY
FDA Proprietary Device Name	VITROS IMMUNODIAGNOSTIC PRODUCTS AFP 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	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	AFP ENZYME IMMUNOASSAY (EIA)
2	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	DSL ACTIVE AFP ELISA	DSL ACTIVE AFP ELISA
3	BIOCHECK, INC. 323 VINTAGE PARK DR. FOSTER CITY, CA 94404 US / 650-573-1968	KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER	ALPHA-FETOPROTEIN EIA TEST KIT
4	FUJIREBIO DIAGNOSTICS AB MAJNABBE TERMINAL GOTHENBURG, SE 41455 SW 610-240-3800 / 463-185-7043	CANAG AFP EIA	IMMUNOLOGICAL TEST FOR ALPHA-FETOPROTEIN (AFP)
5	GENETIC TECHNOLOGIES INC. 6157 N.W. 167TH ST., F-26 MIAMI, FL 33015 US 305-828-3818 / 305-828-3818	GTI-KIT,TEST,ALPHA-FEROPROTEIN FOR TESTICULAR CANCER	ALPHA-FEROPROTEIN FOR TESTICULAR CANCER
6	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	GLOBALEMED AFP EIA	ALPHA-FETOPROTEIN EIA TEST
7	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834	AFP 200 ENZYMUN	AFP 200 ENZYMUN
8	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ELECSYS AFP ASSAY	ALPHA-FETOPROTEIN ASSAY
9	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS AFP	ALPHA-FETOPROTEIN TEST
10	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 AFP	IMMUNOMETRIC ASSAY FOR THE MEASUREMENT OF AFP
11	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 AFP	IMMUNOMETRIC ASSAY FOR THE MEASUREMENT OF AFP
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 AFP	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF AFP
14	TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909	AIA-PACK AFP, ST AIA-PACK AFP	ALPHA-FETOPROTEIN TEST SYSTEM
15	TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909	AIA-PACK AFP, ST AIA-PACK AFP	TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM
16	TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909	AIA-PACK AFP, ST AIA-PACK AFP	ALPHA-FETOPROTEIN TEST SYSTEM

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