TDX / TDX FLX GENTAMICIN 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	LCQ
FDA Classification Name	FLUORESCENT IMMUNOASSAY GENTAMICIN
FDA Device Classification Code	Standards
FDA Regulation Number	862.3450
FDA Common Generic Name	GENTAMICIN
FDA Proprietary Device Name	TDX / TDX FLX GENTAMICIN
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 / TDX FLX GENTAMICIN	GENTAMICIN
2	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	INNOFLUOR GENTAMICIN ASSAY MULTIPLE DIAGNOSIS	INNOFLUOR GENTAMICIN ASSAY MULTIPLE DIAGNOSIS
3	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	INNOFLUOR GENTAMICIN REAGENT SET	GENTAMICIN REAGENT SET