Q.F.A. REFERENCE PLASMA (HUMAN) MANUFACTURED BY INSTRUMENTATION LABORATORY CO.

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Request for Information Form	Contact Information
Company Name	INSTRUMENTATION LABORATORY CO.
Address	526 RT. 303
City, State, Zip	ORANGEBURG, NY 10962
Country	US
FDA Owner/Operator Phone	781-861-4467
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 SYSTEM
FDA Proprietary Device Name	Q.F.A. REFERENCE PLASMA (HUMAN)
FDA Owner / Operator Number	1217183
FDA Owner / Operator Name	INSTRUMENTATION LABORATORY CO.
FDA Establishment Registration Number	2431530
FDA Registered Establishment Name	INSTRUMENTATION LABORATORY CO.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	02-12-99
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	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	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