FLOW-PROTHROMBIN- IVD KIT MANUFACTURED BY DYN-BIOSHAF (2006) LTD.

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Request for Information Form	Contact Information
Company Name	DYN-BIOSHAF (2006) LTD.
Address	7 HA'ESHEL ST.
City, State, Zip	CAESAREA INDUSTRIAL PARK,
Country	IS
FDA Owner/Operator Phone	972-4-8202056
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 IMMUNOLOGICAL TEST SYSTEM
FDA Proprietary Device Name	FLOW-PROTHROMBIN- IVD KIT
FDA Owner / Operator Number	9091405
FDA Owner / Operator Name	DYN-BIOSHAF (2006) LTD.
FDA Establishment Registration Number	3006049087
FDA Registered Establishment Name	DYN-BIOSHAF (2006) LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-29-07
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	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	ASSERA II	PROTHROMBIN ANTIBODY
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