CEDIA PHENOBARBITAL II ASSAY MANUFACTURED BY MICROGENICS CORPORATION

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CEDIA PHENOBARBITAL II 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	DLZ
FDA Classification Name	ENZYME IMMUNOASSAY, PHENOBARBITAL
FDA Device Classification Code	Standards
FDA Regulation Number	862.3660
FDA Common Generic Name	HOMOGENEOUS ENZYME IMMUNOASSAY FOR THE DETERMINATION OF PHENOBARBITAL LEVELS
FDA Proprietary Device Name	CEDIA PHENOBARBITAL II 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 LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	AEROSET PHENOBARBITAL ASSAY AND CALIBRATOR	ASSAY FOR THE DETECTION OF PHENOBARBITAL
2	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	PHENOBARBITAL
3	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	PHENOBARBITAL
4	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	MULTIPLE	ENZYME IMMUNOASSAY, PEHNOBARBITAL
5	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS PHENOBARBITAL METHODS
6	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
7	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	CEDIA PHENOBARBITAL II ASSAY	HOMOGENEOUS ENZYME IMMUNOASSAY FOR THE DETERMINATION OF PHENOBARBITAL LEVELS IN
8	ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	VITROS CHEMISTRY PRODUCTS PHBR SLIDES	PHENOBARBITAL ASSAY
9	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	POLYMEDCO POLY-CHEM SYSTEM, PHENOBARBITAL	PHENOBARBITAL, LUMINAL
10	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX PHENOBARBITAL	PHENOBARBITAL
11	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX PHENBARBITAL	PHENBARBITAL
12	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX PHENOBARBITAL	PHENOBARBITAL
13	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX PHENBARBITAL	PHENBARBITAL
14	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 PHENOBARBITAL	IMMUNOASSAY FOR THE MEASUREMENT OF PHENOBARBITAL
15	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 PHENOBARBITAL	IMMUNOASSAY FOR THE MEASUREMENT OF PHENOBARBITAL
16	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	PHENOBARBITAL TEST SYSTEM