CEDIA DIGITOXIN ASSAY MANUFACTURED BY MICROGENICS CORP.

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CEDIA DIGITOXIN 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	LFM
FDA Classification Name	ENZYME IMMUNOASSAY, DIGITOXIN
FDA Device Classification Code	Standards
FDA Regulation Number	862.3300
FDA Common Generic Name	HOMOGENEOUS ENZYME IMMUNOASSAY OF DIGITOXIN
FDA Proprietary Device Name	CEDIA DIGITOXIN 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	MULTIPLE; AXSYM DIGITOXIN, TDX FLX DIGITOXIN	DIGITOXIN
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE; AXSYM DIGITOXIN, TDX FLX DIGITOXIN	DIGITOXIN
3	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS DIGITOXIN METHODS
4	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	CEDIA DIGITOXIN ASSAY	HOMOGENEOUS ENZYME IMMUNOASSAY DIGITOXIN
5	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX DIGITOXIN	DIGITOXIN
6	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX DIGITOXIN	DIGITOXIN
7	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX DIGITOXIN	DIGITOXIN
8	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX DIGITOXIN	DIGITOXIN
9	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	INNOFLUOR DIGITOXIN REAGENT SET	DIGITOXIN REAGENT SET
10	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS: 180 DIGITOXIN IMMUNOASSAY	DIGITOXIN IMMUNOASSAY
11	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 DIGITOXIN	IMMUNOASSAY FOR THE MEASUREMENT OF DIGITOXIN
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	DIGITOXIN TEST SYSTEM
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 DIGITOXIN	IMMUNOASSAY FOR THE MEASUREMENT OF DIGITOXIN
14	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500 DIGITOXIN	IMMUNOASSAY FOR THE MEASUREMENT OF DIGITOXIN