CEDIA DIGOXIN PLUS ASSAY MANUFACTURED BY MICROGENICS CORPORATION

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CEDIA DIGOXIN PLUS ASSAY

Request for Information Form	Contact Information
Company Name	MICROGENICS CORPORATION
Address	44560-44660 OSGOOD RD
City, State, Zip	FREMONT, CA 94539
Country	US
FDA Owner/Operator Phone	412-490-8425
FDA Medical Specialty Code	TX - Clinical Toxicology
FDA Product Code	KXT
FDA Classification Name	ENZYME IMMUNOASSAY, DIGOXIN
FDA Device Classification Code	Standards
FDA Regulation Number	862.3320
FDA Common Generic Name	HOMOGENEOUS ENZYME IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF DIGOXIN
FDA Proprietary Device Name	CEDIA DIGOXIN PLUS ASSAY
FDA Owner / Operator Number	2517925
FDA Owner / Operator Name	FISHER SCIENTIFIC CO., LLC.
FDA Establishment Registration Number	3005304572
FDA Registered Establishment Name	MICROGENICS CORPORATION
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-22-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of MICROGENICS CORPORATION

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	DIGOXIN
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	DIGOXIN
3	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	DIGOXIN
4	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS DIGOXIN REAGENTS ON THE ACCESS IMMUOASSAY ANALYZER	DIGOXIN EIA
5	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	DIGOXIN
6	BIO-MEDICAL PRODUCTS CORP. 10 HALSTEAD RD. MENDHAM, NJ 07945 US 973-543-7434 / 973-543-7434
7	BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594	VIDAS DIGOXIN ASSAY	ELFA FOR THE QUANTITATIVE MEASUREMENT OF DIGOXIN IN SERUM OR PLASMA
8	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594	VIDAS DIGOXIN ASSAY	ELFA FOR THE QUANTITATIVE MEASUREMENT OF DIGOXIN IN SERUM OR PLASMA
9	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	EMIT	DIGOXIN EIA (BATCH REAGENTS)
10	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS DIGOXIN METHODS
11	GENETIC TECHNOLOGIES INC. 6157 N.W. 167TH ST., F-26 MIAMI, FL 33015 US 305-828-3818 / 305-828-3818	GTI-DIGOXIN MICROPLATE EIA	DIGOXIN EIA
12	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	DIGOXIN MULTIPLE DIAGNOSIS PRODUCTS	DIGOXIN MULTIPLE DIAGNOSIS PRODUCTS
13	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	CEDIA DIGOXIN R, DIGOXIN R'X ASSAY, DIGOXIN XL & SC ASSAYS	HOMOGENEOUS ENZYME IMMUNOASSAY OF DIGOXIN, RABBIT ANTIBODY
14	MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665	DIGOXIN MICROPLATE EIA	DIGOXIN EIA
15	MYERS-STEVENS GROUP 2931 VAIL AVE. COMMERCE, CA 90040 US 323-721-8552 / 903-566-6696	V-TREND DIG ENZYME IMMUNOASSAY TEST KIT	EIA TEST FOR THE QUANTITATION OF DIGOXIN
16	ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	VITROS CHEMISTRY PRODUCTS DGXN SLIDES	DIGOXIN TEST SYSTEM
17	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	POLYMEDCO POLY-CHEM SYSTEM, DIGOXIN	DIGOXIN, LANOXIN
18	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX DIGOXIN	DIGOXIN
19	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX DIGOXIN	DIGOXIN
20	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX DIGOXIN	DIGOXIN
21	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX DIGOXIN	DIGOXIN
22	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ELECRYS DIGOXN	ELECTROCHEMILUMINESCENCE ASSAY
23	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS DIGOXIN ASSAY	DIGOXIN IMMUNOASSAY
24	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	INNOFLUOR DIGOXIN REAGENT SET	DIGOXIN REAGENT SET
25	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 DIGOXIN	IMMUNOASSAY FOR THE MEASUREMENT OF DIGOXIN
26	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 DIGOXIN	IMMUNOASSAY FOR THE MEASUREMENT OF DIGOXIN
27	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	DIOGOXIN REAGENTS
28	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 DIGOXIN	IMMUNOASSAY FOR THE MEASUREMENT OF DIGOXIN

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