K-ASSAY AT-III IMMUNOTURBIDIMETRIC ASSAY MANUFACTURED BY KAMIYA BIOMEDICAL CO.

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Request for Information Form	Contact Information
Company Name	KAMIYA BIOMEDICAL CO.
Address	12779 GATEWAY DR.
City, State, Zip	SEATTLE, WA 98168
Country	US
FDA Owner/Operator Phone	206-575-8068
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	ANTITHROMBIN III IMMUNOTURBIDIMETRIC ASSAY
FDA Proprietary Device Name	K-ASSAY AT-III IMMUNOTURBIDIMETRIC ASSAY
FDA Owner / Operator Number	9001370
FDA Owner / Operator Name	KAMIYA BIOMEDICAL CO.
FDA Establishment Registration Number	2084025
FDA Registered Establishment Name	KAMIYA BIOMEDICAL CO.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	01-02-98
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	NITTO BOSEKI CO., LTD. (MEDICAL DIVISION) 4-1-28 KUDAN-KITA CHIYODA-KU TOKYO, 102-0073 JA 81-3-32384540 / 206-575-8068	N-ASSAY TIA AT-III	ANTI-THROMBIN III ITA
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