MULTIPLE; AXSYM PROCAINAMIDE; TDX/TDXFLX PROCAINAMIDE 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	LAR
FDA Classification Name	ENZYME IMMUNOASSAY, PROCAINAMIDE
FDA Device Classification Code	Standards
FDA Regulation Number	862.3320
FDA Common Generic Name	PROCAINAMIDE
FDA Proprietary Device Name	MULTIPLE; AXSYM PROCAINAMIDE; TDX/TDXFLX PROCAINAMIDE
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	11-21-01
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; AXSYM PROCAINAMIDE; TDX/TDXFLX PROCAINAMIDE	PROCAINAMIDE
2	BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. MISHAWAKA, IN 46544 US 914-524-2955 / 574-256-3430	NO PROPRIETARY NAME LISTED	TEST FOR PROCAINAMIDE IN SERUM OR PLASMA
3	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	ACA PROCAINAMIDE (PROC) ANALYTICAL TEST PACK	ACA PROCAINAMIDE (PROC) ANALYTICAL TEST PACK
4	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	EMIT	PROCAINAMIDE EIA
5	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	CEDIA PROCAUNAMIDE	CEDIA PROCAUNAMIDE
6	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	CEDIA PROCAINAMIDE	CEDIA PROCAINAMIDE