AIA-PACK 27.29, ST AIA-PACK 27.29 MANUFACTURED BY TOSOH AIA, INC.

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AIA-PACK 27.29, ST AIA-PACK 27.29

Request for Information Form	Contact Information
Company Name	TOSOH AIA, INC.
Address	2, IWASEKOSHI-MACHI
City, State, Zip	TOYAMA,
Country	JA
FDA Owner/Operator Phone	813-542-75118
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	FOR THE MEASUREMENT OF CA 27.29 ANTIGEN
FDA Proprietary Device Name	AIA-PACK 27.29, ST AIA-PACK 27.29
FDA Owner / Operator Number	8031673
FDA Owner / Operator Name	TOSOH CORP.
FDA Establishment Registration Number	9612316
FDA Registered Establishment Name	TOSOH AIA, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-09-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of TOSOH AIA, 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 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 AB MAJNABBE TERMINAL GOTHENBURG, SE 41455 SW 610-240-3800 / 463-185-7043	CANAG NSE EIA	IMMUNOLOGICAL TEST FOR NEURON-SPECIFIC ENOLASE (NSE)
6	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US / 610-240-3829	CENTOCOR CA 15-3 RIA	CENTOCOR CA 15-3 RIA
7	ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152	MULTIPLE	CA15-3 CALIBRATOR
8	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
9	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
10	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS: 180 BR	BREAST
11	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
12	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
13	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
14	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
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