ASXYM GENTAMICIN MANUFACTURED BY ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.

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ASXYM GENTAMICIN

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	LCD
FDA Classification Name	ENZYME IMMUNOASSAY, GENTAMICIN
FDA Device Classification Code	Standards
FDA Regulation Number	862.3450
FDA Common Generic Name	GENTAMICIN
FDA Proprietary Device Name	ASXYM 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

Competitors of ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.

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	ASXYM GENTAMICIN	GENTAMICIN
2	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	GENTAMICIN
3	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	GENTAMICIN
4	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS
5	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	EMIT	GENTAMICIN EIA
6	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	CEDIA GENTAMICIN ASSAY	HOMOGENEOUS ENZYME IMMUNOASSAY OF GENTAMICIN
7	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	CEDIA GENTAMICIN ASSAY	HOMOGENEOUS ENZYME IMMUNOASSAY OF GENTAMICIN
8	ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	VITROS CHEMISTRY PRODUCTS GENT REAGENT	GENTAMICIN (GENT) ASSAY
9	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	POLYMEDCO POLY-CHEM SYSTEM, GENTAMICIN	GENTAMICIN, GARAMYCIN
10	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX GENTAMICIN	GENTAMICIN
11	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX GENTAMICIN	GENTAMICIN
12	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX GENTAMICIN	GENTAMICIN
13	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX GENTAMICIN	GENTAMICIN
14	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	QMS GENTAMICIN EIA ASSAY	GENTAMICIN EIA ASSAY
15	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS: 180 GENTAMICIN IMMUNOASSAY	GENTAMICINIMMUNOASSAY
16	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	GENTAMICIN TEST SYSTEM
17	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE 2000 GENTAMICIN	IMMUNOASSAY FOR THE MEASUREMENT OF GENTAMICIN
18	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE 2000 GENTAMICIN	IMMUNOASSAY FOR THE MEASUREMENT OF GENTAMICIN