GTI-AFP MICROPLATE ELISA MANUFACTURED BY GENETIC TECHNOLOGIES INC.

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Request for Information Form	Contact Information
Company Name	GENETIC TECHNOLOGIES INC.
Address	6157 N.W. 167TH ST., F-26
City, State, Zip	MIAMI, FL 33015
Country	US
FDA Owner/Operator Phone	305-828-3818
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	KTJ
FDA Classification Name	SYSTEM, TEST, ALPHA-FETOPROTEIN, RIA
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	AFP ELISA
FDA Proprietary Device Name	GTI-AFP MICROPLATE ELISA
FDA Owner / Operator Number	9100442
FDA Owner / Operator Name	GENETIC TECHNOLOGIES INC.
FDA Establishment Registration Number	3005924399
FDA Registered Establishment Name	GENETIC TECHNOLOGIES INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	05-15-07
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	AMERITEK USA, INC. 125 130 ST. SE, #200 EVERETT, WA 98208 US 425-379-2580 / 425-379-2580	DBEST AFP TEST KIT	AFP TEST KIT
2	COVANCE RESEARCH PRODUCTS, INC. 180 RUSTCRAFT RD., SUITE 140 DEDHAM, MA 02026 US 800-922-2226 / 781-915-1405	ALPHA 1 FETOPROTEIN, POLYCLONAL ANTIBODY	AFP, POLYCLONAL ANTIBDOY
3	MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665	AFP MICROPLATE ELISA	AFP ELISA
4	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	COAT-A-COUNT AFP IRMA	RADIOIMMUNOASSAY FOR THE MEASUREMENT OF ALPHA-FETOPROTEIN, AFP