ASSERA II 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	IM - Immunology
FDA Product Code	DDF
FDA Classification Name	PROTHROMBIN, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	General Controls
FDA Regulation Number	866.5735
FDA Common Generic Name	PROTHROMBIN ANTIBODY
FDA Proprietary Device Name	ASSERA II
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	DYN-BIOSHAF (2006) LTD. 7 HA'ESHEL ST. CAESAREA INDUSTRIAL PARK, 38900 IS 972-4-8202056 / 603-369-3550	FLOW-PROTHROMBIN- IVD KIT	PROTHROMBIN IMMUNOLOGICAL TEST SYSTEM
2	STAGO R & D 125 AVE. LOUIS ROCHE GENNEVILLIERS, 92230 FR 33-146-88 20 20 / 33-146-854851	PROTHROMBIN	PURIFIED PROTHROMBIN
3	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	VERICAL SET	VERICAL SET