HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONTROL PLASMA MANUFACTURED BY INTERNATIONAL TECHNIDYNE CORP.

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Request for Information Form	Contact Information
Company Name	INTERNATIONAL TECHNIDYNE CORP.
Address	23 NEVSKY ST.
City, State, Zip	EDISON, NJ 08820
Country	US
FDA Owner/Operator Phone	732-548-5700
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 TEST AND CONTROL REAGENT
FDA Proprietary Device Name	HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONTROL PLASMA
FDA Owner / Operator Number	2250033
FDA Owner / Operator Name	INTERNATIONAL TECHNIDYNE CORPORATION
FDA Establishment Registration Number	2250033
FDA Registered Establishment Name	INTERNATIONAL TECHNIDYNE CORP.
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	12-22-93
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	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS	FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS
2	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
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