MULTIPLE MANUFACTURED BY ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.

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Request for Information Form	Contact Information
Company Name	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
Address	KM 58.0, CARRETERA 2 CRUCE DAVILA
City, State, Zip	BARCELONETA, PR 00617
Country	US
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	TX - Clinical Toxicology
FDA Product Code	DML
FDA Classification Name	NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD
FDA Device Classification Code	Standards
FDA Regulation Number	862.3040
FDA Common Generic Name	ETHANOL
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	2623532
FDA Registered Establishment Name	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-01-02
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 LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	ETHANOL
2	ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	MULTIPLE	ETHANOL
3	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	MULTIPLE	NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL
4	VARIAN INC 25200 COMMERCENTRE DR. LAKE FOREST, CA 92630 US 650-424-5078 / 949-639-5415	ON-SITE ALCOHOL	ALCOHOL TEST