ELECTRODE, ION SPECIFIC, UREA NITROGEN MANUFACTURED BY ABBOTT POINT OF CARE CANADA LIMITED

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Request for Information Form	Contact Information
Company Name	ABBOTT POINT OF CARE CANADA LIMITED
Address	185 CORKSTOWN ROAD
City, State, Zip	NEPEAN, ONTARIO,
Country	CA
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CDS
FDA Classification Name	ELECTRODE, ION SPECIFIC, UREA NITROGEN
FDA Device Classification Code	Standards
FDA Regulation Number	862.1770
FDA Common Generic Name	BUN TEST
FDA Proprietary Device Name	ELECTRODE, ION SPECIFIC, UREA NITROGEN
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	3005643513
FDA Registered Establishment Name	ABBOTT POINT OF CARE CANADA LIMITED
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	03-31-06
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	ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD KANATA, ONTARIO, K2L 1T9 CA 847-937-6100 / 847-938-3471	ELECTRODE, ION SPECIFIC, UREA NITROGEN	BUN TEST
2	ABBOTT POINT OF CARE INC. 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520 US 847-937-6100 / 847-938-3471	ELECTRODE, ION SPECIFIC, UREA NITROGEN	BUN TEST
3	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	BLOOD UREA NITROGEN
4	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	BLOOD UREA NITROGEN
5	GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 BREA, CA 92821 US 714-529-7125 / 714-529-7166	BUN3	BUN3
6	INTERNATIONAL TECHNIDYNE CORPORATION 20 CORPORATE PLACE SOUTH PISCATAWAY, NJ 08854 US 732-548-5700 / 732-548-5700 265	IRMA BLOOD ANALYZER	BLOOD ANALYZER
7	INTERNATIONAL TECHNIDYNE INCORPORATED 2656 PATTON RD. ROSEVILLE, MN 55113 US 732-548-5700 / 732-548-5700 265	IRMA SL	BLOOD ANALYZER
8	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	MULTIPLE	VARIOUS
9	OPTI MEDICAL SYSTEMS INC. 235 HEMBREE PARK DRIVE ROSWELL, GA 30076 US 207-556-8155 / 770-510-4444 4466	OPTI CRITICAL CARE ANALYZER	AUTOMATED BLOOD GAS-ELECTROLYTE ANALYZER
10	VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553	MULTIPLE	VARIOUS UREA/UREA NITROGEN REAGENTS