STAT--CRIT MANUFACTURED BY INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS
Address	2 RESEARCH WAY
City, State, Zip	PRINCETON, NJ 08540
Country	US
FDA Owner/Operator Phone	781-674-3900
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GKF
FDA Classification Name	INSTRUMENT, HEMATOCRIT, AUTOMATED
FDA Device Classification Code	Standards
FDA Regulation Number	864.5600
FDA Common Generic Name	STAT--CRIT
FDA Proprietary Device Name	STAT--CRIT
FDA Owner / Operator Number	9006731
FDA Owner / Operator Name	INVERNESS MEDICAL INNOVATIONS, INC.
FDA Establishment Registration Number	3003764480
FDA Registered Establishment Name	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	09-04-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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5	SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY CARLSBAD, CA 92011 US 45-38-273827 / 45-38-273617	MULTIPLE	VARIOUS DODELS OF BLOOD ANALYZERS
6	SEPARATION TECHNOLOGY, INC. 1096 RAINER DR. ALTAMONTE SPRINGS, FL 32714 US 412-490-8425 / 412-490-8425	ULTRACRIT HEMATOCRIT MEASUREMENT DEVICE	AUTOMATED HEMATOCRIT INSTRUMENT
7	SORIN GROUP USA, INC. 14401 WEST 65TH WAY ARVADA, CO 80004 US 303-467-6306 / 303-467-6306	SATURATION-HEMATOCRIT MONITOR	HEMATOCRIT MONITOR