CEDIA DAU NEGATIVE CALIBRATOR MANUFACTURED BY MICROGENICS CORP.

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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	DLT
FDA Classification Name	HEMAGGLUTINATION, OPIATES
FDA Device Classification Code	Standards
FDA Regulation Number	862.3650
FDA Common Generic Name	DRUG OF ABUSE NEGATIVE CALIBRATOR FOR USE OF THE MICROGENICS CEDIA SAU ASSAYS
FDA Proprietary Device Name	CEDIA DAU NEGATIVE CALIBRATOR
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
FDA Listing Date	08-23-94
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 companyies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	CEDIA DAU NEGATIVE CALIBRATOR	DRUG OF ABUSE NEGATIVE CALIBRATOR FOR USE OF THE MICROGENICS CEDIA DAU ASSAYS