MULTIPLE MANUFACTURED BY BECKMAN COULTER, INC. (IRELAND)

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Request for Information Form	Contact Information
Company Name	BECKMAN COULTER, INC. (IRELAND)
Address	MERVUE BUSINESS PARK
City, State, Zip	GALWAY,
Country	EI
FDA Owner/Operator Phone	714-871-4848
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	BLOOD UREA NITROGEN
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	2050012
FDA Owner / Operator Name	BECKMAN COULTER, INC.
FDA Establishment Registration Number	8020879
FDA Registered Establishment Name	BECKMAN COULTER, INC. (IRELAND)
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-22-98
FDA Listing Status Code	Tentatively Out of Business
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 CANADA LIMITED 185 CORKSTOWN ROAD NEPEAN, ONTARIO, K2H 8V4 CA 847-937-6100 / 847-938-3471	ELECTRODE, ION SPECIFIC, UREA NITROGEN	BUN TEST
3	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
4	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 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