ELISA MITOCHONDRIAL AB (EASY ELISA MITOCHRDRIAL AB) MANUFACTURED BY CALBIOTECH, INC.

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Request for Information Form	Contact Information
Company Name	CALBIOTECH, INC.
Address	10461 AUSTIN DR., #G
City, State, Zip	SPRING VALLEY, CA 91978
Country	US
FDA Owner/Operator Phone	619-660-6162
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JLT
FDA Classification Name	ACID, PYRUVIC, ENZYMATIC (U.V.)
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1655
FDA Common Generic Name	MITOCHONDRIAL ANTIBODY (MA) ELISA
FDA Proprietary Device Name	ELISA MITOCHONDRIAL AB (EASY ELISA MITOCHRDRIAL AB)
FDA Owner / Operator Number	9046880
FDA Owner / Operator Name	CALBIOTECH, INC.
FDA Establishment Registration Number	2090110
FDA Registered Establishment Name	CALBIOTECH, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	02-18-02
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	GENETIC TECHNOLOGIES INC. 6157 N.W. 167TH ST., F-26 MIAMI, FL 33015 US 305-828-3818 / 305-828-3818	GTI-ELISA MITOCHONDRIAL AB (EASY ELISA MITOCHONDRIAL AB)	MITOCHONDRIAL ANTIBODY (MA) ELISA