NO PROPRIETARY NAME LISTED MANUFACTURED BY BAYER HEALTHCARE, LLC

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Request for Information Form	Contact Information
Company Name	BAYER HEALTHCARE, LLC
Address	430 SOUTH BEIGER ST.
City, State, Zip	MISHAWAKA, IN 46544
Country	US
FDA Owner/Operator Phone	914-524-2955
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	TEST FOR PROCAINAMIDE IN SERUM OR PLASMA
FDA Proprietary Device Name	NO PROPRIETARY NAME LISTED
FDA Owner / Operator Number	2425130
FDA Owner / Operator Name	BAYER HEALTHCARE, LLC
FDA Establishment Registration Number	1826988
FDA Registered Establishment Name	BAYER HEALTHCARE, LLC
FDA Operation Code(s)
FDA Listing Date
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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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	MULTIPLE; AXSYM PROCAINAMIDE; TDX/TDXFLX PROCAINAMIDE	PROCAINAMIDE
2	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
3	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	EMIT	PROCAINAMIDE EIA
4	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
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