TDX/TDXFLXLIDOCAINE 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	KLR
FDA Classification Name	ENZYME IMMUNOASSAY, LIDOCAINE
FDA Device Classification Code	Standards
FDA Regulation Number	862.3555
FDA Common Generic Name	LIDOCAINE
FDA Proprietary Device Name	TDX/TDXFLXLIDOCAINE
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	04-30-02
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	TDX/TDXFLXLIDOCAINE	LIDOCAINE
2	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	EMIT	LIDOCAINE EIA
3	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	ACA LIDOCAIN (LIDO) ANALYTICAL TEST PACK	ACA LIDOCAIN (LIDO) ANALYTICAL TEST PACK
4	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	MULTIPLE	LIDOCAINE ENZYME IMMUNOASSAY
5	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	MULTIPLE	LIDOCAINE ENZYME IMMUNOASSAY