ELECTRODE, ION BASED, ENZYMATIC, CREATININE MANUFACTURED BY ABBOTT POINT OF CARE INC.

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Request for Information Form	Contact Information
Company Name	ABBOTT POINT OF CARE INC.
Address	104 WINDSOR CENTER DR.
City, State, Zip	EAST WINDSOR, NJ 08520
Country	US
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CGL
FDA Classification Name	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1225
FDA Common Generic Name	CREATINE TEST
FDA Proprietary Device Name	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	2245578
FDA Registered Establishment Name	ABBOTT POINT OF CARE INC.
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	11-25-99
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 185 CORKSTOWN ROAD NEPEAN, ONTARIO, K2H 8V4 CA 847-937-6100 / 847-938-3471	I-STAT CREATININE TEST	CREATININE TEST
2	ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD KANATA, ONTARIO, K2L 1T9 CA 847-937-6100 / 847-938-3471	ELECTRODE, ION BASED, ENZYMATIC, CREATININE	CREATINE TEST
3	E-Z-EM, INC. 750 SUMMA AVE. WESTBURY, NY 11590 US 800-544-4624 3407 / 516-333-8230 3407	E-Z-CHEM	CREATININE TEST SYSTEM
4	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	NOVA 16 CRT ANALYZER	NOVA 16 CRT ANALYZER