MULTIPLE HEMATOCRIT CONTROLS MANUFACTURED BY BIONOSTICS, INC.

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Request for Information Form	Contact Information
Company Name	BIONOSTICS, INC.
Address	7 JACKSON RD.
City, State, Zip	DEVENS, MA 01434
Country	US
FDA Owner/Operator Phone	978-772-7070
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	HEMATOCRIT CONTROLS
FDA Proprietary Device Name	MULTIPLE HEMATOCRIT CONTROLS
FDA Owner / Operator Number	1220649
FDA Owner / Operator Name	BIONOSTICS, INC.
FDA Establishment Registration Number	1220649
FDA Registered Establishment Name	BIONOSTICS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	10-31-00
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	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	MULTIPLE	HEMATOCRIT CONTROL
3	INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 2 RESEARCH WAY PRINCETON, NJ 08540 US 781-674-3900 / 609-627-8038	STAT-CRIT	STAT-CRIT
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