GOAT ANTISERA TO HUMAN FIBRINOGEN MANUFACTURED BY BECKMAN COULTER, INC.

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Request for Information Form	Contact Information
Company Name	BECKMAN COULTER, INC.
Address	1000 LAKE HAZELTINE DR.
City, State, Zip	CHASKA, MN 55318
Country	US
FDA Owner/Operator Phone	714-871-4848
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	GOAT ANTISERA TO HUMAN FIBRINOGEN
FDA Proprietary Device Name	GOAT ANTISERA TO HUMAN FIBRINOGEN
FDA Owner / Operator Number	2050012
FDA Owner / Operator Name	BECKMAN COULTER, INC.
FDA Establishment Registration Number	2122870
FDA Registered Establishment Name	BECKMAN COULTER, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date
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	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	ASSERA FI	FIBRINOGEN ANTIBODY
2	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	MULTIPLE	VARIOUS
3	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068	K-ASSAY FIBRINOGEN IMMUNOTURBIDIMETRIC ASSAY	FIBRINOGEN IMMUNOTURBIDIMETRIC ASSAY
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