TDX/TDXFLX AMIKACIN 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	KLQ
FDA Classification Name	RADIOIMMUNOASSAY, AMIKACIN
FDA Device Classification Code	Standards
FDA Regulation Number	862.3035
FDA Common Generic Name	AMIKACIN
FDA Proprietary Device Name	TDX/TDXFLX AMIKACIN
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	TDX/TDXFLX AMIKACIN	AMIKACIN
2	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS AMIKACIN TESTS
3	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	INNOFLUOR AMIKACIN ASSAY SY MULTIPLE DIAGNOSIS PRODUCTS	INNOFLUOR AMIKACIN ASSAY SY MULTIPLE DIAGNOSIS PRODUCTS
4	MEDICAL CHEMICAL CORP. 19430 VAN NESS AVE TORRANCE, CA 90501 US 310-787-6800 / 310-787-6800 235	CHLORAZOL BLACK E STAIN	CHLORAZOL BLACK E STAIN
5	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX AMIKACIN	AMIKACIN
6	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX AMIKACIN	AMIKACIN
7	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	INNOFLUOR AMIKACIN REAGENT SET	AMIKACIN REAGENT SET