FLOW-BETA2GP1- 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	DDN
FDA Classification Name	BETA-2-GLYCOPROTEIN I, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	General Controls
FDA Regulation Number	866.5430
FDA Common Generic Name	BETA-2-GLYCOPROTEIN I IMMUNOLOGICAL TEST SYSTEM
FDA Proprietary Device Name	FLOW-BETA2GP1- 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

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	MULTIPLE	VARIOUS
2	EUROIMMUN US LLC 429 ROCKAWAY VALLEY RD. UNIT 1200 BOONTON, NJ 07005 US 973-402-6101 / 973-402-6101	EUROIMMUN BETA-2-GLYCOPROTEIN 1 KIT	BETA-2- GLYCOPROTEIN 1
3	STAGO R & D 125 AVE. LOUIS ROCHE GENNEVILLIERS, 92230 FR 33-146-88 20 20 / 33-146-854851	BETA 2 GLYCOPROTEIN 1, HUMAN	BETA 2 GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL