K-ASSAY FIBRINOGEN 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	DAZ
FDA Classification Name	FIBRINOGEN AND SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	864.7340
FDA Common Generic Name	FIBRINOGEN IMMUNOTURBIDIMETRIC ASSAY
FDA Proprietary Device Name	K-ASSAY FIBRINOGEN 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	07-11-97
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. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	GOAT ANTISERA TO HUMAN FIBRINOGEN	GOAT ANTISERA TO HUMAN FIBRINOGEN
2	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	ASSERA FI	FIBRINOGEN ANTIBODY
3	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	MULTIPLE	VARIOUS
4	KENT LABORATORIES, INC. 777 JORGENSEN PLACE BELLINGHAM, WA 98226 US 360-398-8641 / 360-398-8641	ANTISERUM TO FIBRINOGEN	ANTISERUM TO FIBRINOGEN
5	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 FIB	FIBRINOGEN ITA
6	STAGO R & D 125 AVE. LOUIS ROCHE GENNEVILLIERS, 92230 FR 33-146-88 20 20 / 33-146-854851	ANTI-FIBRINOGEN	FIBRINOGEN ANTISERUM