ASSERA FI MANUFACTURED BY DIAGNOSTICA-STAGO

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Request for Information Form	Contact Information
Company Name	DIAGNOSTICA-STAGO
Address	2 RUE PIERRE FOSSATI
City, State, Zip	FRANCONVILLE,
Country	FR
FDA Owner/Operator Phone	33-146-88 20 20
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 ANTIBODY
FDA Proprietary Device Name	ASSERA FI
FDA Owner / Operator Number	8020753
FDA Owner / Operator Name	DIAGNOSTICA STAGO
FDA Establishment Registration Number	9610666
FDA Registered Establishment Name	DIAGNOSTICA-STAGO
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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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	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