MULTIPLE MANUFACTURED BY MICROGENICS CORPORATION

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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	DMT
FDA Classification Name	ENZYMATIC METHOD, ALCOHOL DEHYDROGENASE, ULTRAVIOLET
FDA Device Classification Code	Standards
FDA Regulation Number	862.3040
FDA Common Generic Name	ALCOHOL TEST
FDA Proprietary Device Name	MULTIPLE
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

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	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	ALCOHOL TEST SYSTEM
2	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396	ETHANOL (RATE) ASSAY	ETHANOL (RATE) ASSAY
3	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	MULTIPLE	ALCOHOL TEST
4	NOVX SYSTEMS INC. 185 RENFREW DRIVE MARKHAM, ONTARIO, L3R 6G3 CA 905-474-5051ext240 / 905-474-5051x240	IMDX MMT-1 REAGENT: ETHYL ALCOHOL ASSAY	ENZYMATIC METHOD, ALCOHOL DEHYDROGENASE, UV
5	REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501	RAICHEM	ENZYMATIC DETERMINATION OF ETHYL ALCOHOL IN BLOOD OR SERUM
6	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ALCOHOL U.V.	ALCOHOL
7	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	MULTIGENT ETHANOL	ALCOHOL TEST SYSTEM