FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS MANUFACTURED BY DADE BEHRING MARBURG GMBH

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Request for Information Form	Contact Information
Company Name	DADE BEHRING MARBURG GMBH
Address	76 EMIL-VON-BEHRING STRASSE
City, State, Zip	MARBURG,
Country	GM
FDA Owner/Operator Phone	847-267-5300
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GFK
FDA Classification Name	FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS
FDA Device Classification Code	Standards
FDA Regulation Number	864.7340
FDA Common Generic Name	FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS
FDA Proprietary Device Name	FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS
FDA Owner / Operator Number	9017031
FDA Owner / Operator Name	DADE BEHRING, INC.
FDA Establishment Registration Number	9610806
FDA Registered Establishment Name	DADE BEHRING MARBURG GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	02-25-99
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	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	Q.F.A. REFERENCE PLASMA (HUMAN)	FIBRINOGEN DETERMINATION SYSTEM
2	INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. EDISON, NJ 08820 US 732-548-5700 / 732-548-5700 265	HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONTROL PLASMA	FIBRINOGEN TEST AND CONTROL REAGENT
3	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	NOVA CHEMISTRY ANALYZERS, NOVA 1,5,8,11,13,14,16, STAT PROFILE PLUS 1,2,4,5,6,9,	AUTOMATED HEMATOCRIT INSTRUMENT