CEDIA GENTAMICIN ASSAY MANUFACTURED BY MICROGENICS CORP.

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CEDIA GENTAMICIN ASSAY

Request for Information Form	Contact Information
Company Name	MICROGENICS CORP.
Address	46360 FREMONT BLVD
City, State, Zip	FREMONT, CA 94538
Country	US
FDA Owner/Operator Phone	412-490-8425
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	HOMOGENEOUS ENZYME IMMUNOASSAY OF GENTAMICIN
FDA Proprietary Device Name	CEDIA GENTAMICIN ASSAY
FDA Owner / Operator Number	2517925
FDA Owner / Operator Name	FISHER SCIENTIFIC CO., LLC.
FDA Establishment Registration Number	2937369
FDA Registered Establishment Name	MICROGENICS CORP.
FDA Operation Code(s)	MM - Manufacturer RR - Repackager/Relabeller
FDA Listing Date	12-09-92
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of MICROGENICS CORP.

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 DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	ASXYM GENTAMICIN	GENTAMICIN
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	ASXYM GENTAMICIN	GENTAMICIN
3	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	GENTAMICIN
4	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	GENTAMICIN
5	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	EMIT	GENTAMICIN EIA
6	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS
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 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE 2000 GENTAMICIN	IMMUNOASSAY FOR THE MEASUREMENT OF GENTAMICIN
16	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS: 180 GENTAMICIN IMMUNOASSAY	GENTAMICINIMMUNOASSAY
17	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
18	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	GENTAMICIN TEST SYSTEM