CANAG NSE EIA MANUFACTURED BY FUJIREBIO DIAGNOSTICS AB

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CANAG NSE EIA

Request for Information Form	Contact Information
Company Name	FUJIREBIO DIAGNOSTICS AB
Address	MAJNABBE TERMINAL
City, State, Zip	GOTHENBURG,
Country	SW
FDA Owner/Operator Phone	610-240-3800
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	MOI
FDA Classification Name	SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
FDA Device Classification Code	Standards
FDA Regulation Number	866.6010
FDA Common Generic Name	IMMUNOLOGICAL TEST FOR NEURON-SPECIFIC ENOLASE (NSE)
FDA Proprietary Device Name	CANAG NSE EIA
FDA Owner / Operator Number	9092870
FDA Owner / Operator Name	FUJIREBIO DIAGNOSTICS, INC.
FDA Establishment Registration Number	3000125561
FDA Registered Establishment Name	FUJIREBIO DIAGNOSTICS AB
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	10-21-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of FUJIREBIO DIAGNOSTICS AB

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 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	ENZYME IMMUNOASSAY TO MEASURE CA 15-3 IN HUMAN SERUM OR PLASMA
2	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS	IMMUNOLOGICAL TEST FOR CA15-3 ANTIGEN
3	CANCER TRACERS INC. 6931 ARLINGTON ROAD, STE. 402 BETHESDA, MD 20814 US 301-652-5001 / 301-652-5001 16	ONCO DETECT ULTRASENSITIVE ENZYME IMMUNOASSAY	PSA ASSAY
4	COVANCE RESEARCH PRODUCTS, INC. 180 RUSTCRAFT RD., SUITE 140 DEDHAM, MA 02026 US 800-922-2226 / 781-915-1405	CA15-3 MONOCLONAL ANTIBODY	DF3 MONOCLONAL ANTIBODY
5	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US / 610-240-3829	CENTOCOR CA 15-3 RIA	CENTOCOR CA 15-3 RIA
6	ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152	MULTIPLE	CA15-3 CALIBRATOR
7	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS CA 15-3 TEST SYSTEM	CA 15-3 IMMUNOASSAY
8	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ELECSYS CA 15-3 ASSAY	ELECTROCHEMILUNUNESCENCE ASSAY FOR DETERMINATION OF CA 15-3
9	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 BR-MA (C15-3)	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF CA 15-3 ANTIGEN
10	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	BAYER IMMUNO 1 HER-2/NEU ASSAY, FOR FOLLOW-UP AND MONITORING PATIENTS WITH METAS	HER-2/NEU ASSAY FOR BAYER IMMUNO 1 ANALYZER
11	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 BR-MA (C15-3)	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF CA 15-3 ANTIGEN
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS: 180 BR	BREAST
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 BR-MA	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF CA 15-3 ANTIGEN
14	TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909	AIA-PACK 27.29, ST AIA-PACK 27.29	FOR THE MEASUREMENT OF CA 27.29 ANTIGEN
15	TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909	AIA-PACK 27.29, ST AIA-PACK 27.29	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 27.29, ST AIA-PACK 27.29	FOR THE MEASUREMENT OF CA 27.29 ANTIGEN
17	TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909	AIA-PACK 27.29	FOR THE MEASUREMENT OF CA27.29 ANTIGEN

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