N-ASSAY TIA AT-III MANUFACTURED BY NITTO BOSEKI CO., LTD. (MEDICAL DIVISION)

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Request for Information Form	Contact Information
Company Name	NITTO BOSEKI CO., LTD. (MEDICAL DIVISION)
Address	4-1-28 KUDAN-KITA CHIYODA-KU
City, State, Zip	TOKYO,
Country	JA
FDA Owner/Operator Phone	81-3-32384540
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	DDQ
FDA Classification Name	ANTIGEN, ANTISERUM, CONTROL, ANTITHROMBIN III
FDA Device Classification Code	Standards
FDA Regulation Number	864.7060
FDA Common Generic Name	ANTI-THROMBIN III ITA
FDA Proprietary Device Name	N-ASSAY TIA AT-III
FDA Owner / Operator Number	9028746
FDA Owner / Operator Name	NITTO BOSEKI CO., LTD. (MEDICAL DIVISION)
FDA Establishment Registration Number	1000403749
FDA Registered Establishment Name	NITTO BOSEKI CO., LTD. (MEDICAL DIVISION)
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-09-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	ANTITHROMBIN III
2	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	ANTITHROMBIN III
3	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS
4	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
5	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	ANTI-HUMAN ANTITHROMBIN III SERUM	ANTI-HUMAN III ANTISERUM-NEPHELOMETRIC AND IGG FRACTION
6	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068	K-ASSAY AT-III IMMUNOTURBIDIMETRIC ASSAY	ANTITHROMBIN III IMMUNOTURBIDIMETRIC ASSAY
7	STAGO R & D 125 AVE. LOUIS ROCHE GENNEVILLIERS, 92230 FR 33-146-88 20 20 / 33-146-854851	ANTI-ANTITHROMBIN III	ANTITHROMBIN III ANTISERUM
8	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	HUMAN ANTITHROBIN III RID KIT	ANTITHROMBIN III RID KIT
9	THE BINDING SITE, INC. 5889 OBERLIN DR., SUITE 101 SAN DIEGO, CA 92121 US 858-453-9177 / 858-453-9177		IMMUNOLOGICAL TEST SYSTEM
10	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	VERICAL SET	VERICAL SET