ASSERA XIII-A 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	DBT
FDA Classification Name	FACTOR XIII A, S, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	General Controls
FDA Regulation Number	866.5330
FDA Common Generic Name	FACTOR XIII-A ANTIBODY
FDA Proprietary Device Name	ASSERA XIII-A
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

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	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000	HEMOSIL FACTOR XIII ANTIGEN	FACTOR XIII LATEX AGGLUTINATION TEST
2	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	HEMOSIL FACTOR XIII ANTIGEN	FACTOR XIII TEST
3	STAGO R & D 125 AVE. LOUIS ROCHE GENNEVILLIERS, 92230 FR 33-146-88 20 20 / 33-146-854851	ANTI FACTOR XIII-S ANTISERUM	FACTOR XIII-S ANTISERUM