ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MANUFACTURED BY BECKMAN COULTER, INC.

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ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

Request for Information Form	Contact Information
Company Name	BECKMAN COULTER, INC.
Address	1000 LAKE HAZELTINE DR.
City, State, Zip	CHASKA, MN 55318
Country	US
FDA Owner/Operator Phone	714-871-4848
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	DHX
FDA Classification Name	SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
FDA Device Classification Code	Standards
FDA Regulation Number	866.6010
FDA Common Generic Name	CEA ENZYME IMMUNOASSAY
FDA Proprietary Device Name	ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Owner / Operator Number	2050012
FDA Owner / Operator Name	BECKMAN COULTER, INC.
FDA Establishment Registration Number	2122870
FDA Registered Establishment Name	BECKMAN COULTER, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	07-29-99
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of BECKMAN COULTER, 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	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS CEA ASSAYS
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS
3	AMERITEK USA, INC. 125 130 ST. SE, #200 EVERETT, WA 98208 US 425-379-2580 / 425-379-2580	DBEST ONE STEP CEA TEST KIT	CEA TEST KIT
4	BIOCHECK, INC. 323 VINTAGE PARK DR. FOSTER CITY, CA 94404 US / 650-573-1968	BIOCHECK CEA EIA TEST KIT	CARCINOEMBRYONIC ANTIGEN EIA TEST KIT
5	BIO-RAD ROUTE DE CASSEL STEENVOORDE, 59114 FR 331--4--795-6000 / 33-1-47956138	ACCESS CEA	VARIOUS EIA ASSAYS
6	COVANCE RESEARCH PRODUCTS, INC. 180 RUSTCRAFT RD., SUITE 140 DEDHAM, MA 02026 US 800-922-2226 / 781-915-1405	CEA, POLYCLONAL ANTIBODY	CEA, POLYCLONAL ANTIBODY
7	CTK BIOTECH, INC. 6748 NANCY RIDGE DR. SAN DIEGO, CA 92121 US 858-457-8698 / 858-457-8698	CEA DETECT ELISA KIT	CEA ELISA KIT
8	GENETIC TECHNOLOGIES INC. 6157 N.W. 167TH ST., F-26 MIAMI, FL 33015 US 305-828-3818 / 305-828-3818	GTI-CEA MICROPLATE ELISA	CEA ELISA
9	MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665	CEA MICROPLATE ELISA	CEA ELISA
10	ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152	MULTIPLE	CEA ASSAY
11	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834	CEA ENZYMUN	CEA ENZYMUN
12	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS CEA ASSAY	CARCINOEMBRYONIC ANTIGEN IMMUNOASSAY
13	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ELECSYS CEA ASSAY	ELECTROCHEMILUMINESCENCE ASSAY FOR THE DETERMINATION OF CARCINOEMLORYONIC
14	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS CARCINOEEMBRYONIC (CEA) ASSAY	CARCINOEMBRYONIC (CEA) ASSAY
15	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN	SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
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 CEA	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF CARCINOEMBRYONIC
17	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 CEA	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF CARCINOEMBRYONI
18	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 CEA	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF CARCINOEMBRYONI
19	TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909	AIA-PACK CEA, ST AIA-PACK CEA	FOR THE MEASUREMENT OF CARCINOEMBRYONIC ANTIGEN, CEA
20	TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909	AIA-PACK CEA, ST AIA-PACK CEA	SYSTEMIC LUPUS ERYTHEMATOSUS IMMUNOLOGICAL TEST SYSTEM
21	TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909	AIA-PACK CEA, ST AIA-PACK CEA	FOR THE MEASUREMENT OF CARCINOEMBRYONIC ANTIGEN, CEA