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	GLK
FDA Classification Name	CONTROL, HEMATOCRIT
FDA Device Classification Code	Standards
FDA Regulation Number	864.8625
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

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	AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE. CARLSBAD, CA 92008 US 760-431-7922 / 760-431-7922	AUDIT MICROTUBE MICROHEMATOCRIT	HEMATOCRIT CONTROLS
2	BIONOSTICS, INC. 7 JACKSON RD. DEVENS, MA 01434 US 978-772-7070 / 978-772-7070 220	MULTIPLE HEMATOCRIT CONTROLS	HEMATOCRIT CONTROLS
3	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	MULTIPLE	HEMATOCRIT CONTROL
4	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	HEMATOCRIT CONTROLS	HEMATOCRIT CONTROLS
5	RICHMOND DIAGNOSTICS, INC. 100 JERSEY AVE., SUITE 202-A, BLDG. B NEW BRUNSWICK, NJ 08901 US 732-246-2429 / 732-246-2429	HEMATACHEK	HEMATOCRIT CONTROL
6	SEPARATION TECHNOLOGY, INC. 1096 RAINER DR. ALTAMONTE SPRINGS, FL 32714 US 412-490-8425 / 412-490-8425	HEMATACHEK AND ULTRACHEK	HEMATOLOGY QUALITY CONTROL MIXTURE