CO2 REAGENT MANUFACTURED BY GENCHEM, INC.

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Request for Information Form	Contact Information
Company Name	GENCHEM, INC.
Address	471 W. LAMBERT RD., SUITE 107
City, State, Zip	BREA, CA 92821
Country	US
FDA Owner/Operator Phone	714-529-7125
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JFL
FDA Classification Name	PH RATE MEASUREMENT, CARBON-DIOXIDE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1160
FDA Common Generic Name	CO2 REAGENT
FDA Proprietary Device Name	CO2 REAGENT
FDA Owner / Operator Number	9060807
FDA Owner / Operator Name	GENCHEM, INC.
FDA Establishment Registration Number	3005432203
FDA Registered Establishment Name	GENCHEM, INC.
FDA Operation Code(s)	ME - Contract Manufacturer MM - Manufacturer
FDA Listing Date	11-10-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD KANATA, ONTARIO, K2L 1T9 CA 847-937-6100 / 847-938-3471	I-STAT TC02 TEST	TOTAL CARBON DIOXIDE
2	ABBOTT POINT OF CARE CANADA LIMITED 185 CORKSTOWN ROAD NEPEAN, ONTARIO, K2H 8V4 CA 847-937-6100 / 847-938-3471	I-STAT TCO2 TEST	TOTAL CARBON DIOXIDE
3	ABBOTT POINT OF CARE INC. 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520 US 847-937-6100 / 847-938-3471	I-STAT TC02 TEST	TOTAL CARBON DIOXIDE
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5	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	CARBON DIOXIDE
6	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	CARBON DIOXIDE
7	CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272	CO2 ALKALINE BUFFER REAGENT	CO2 BUFFER
8	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	MULTIPLE	VARIOUS
9	VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553	MULTIPLE	VARIOUS TOTAL CARBON DIOXIDE REAGENTS