DBEST AFP TEST KIT MANUFACTURED BY AMERITEK USA, INC.

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Request for Information Form	Contact Information
Company Name	AMERITEK USA, INC.
Address	125 130 ST. SE, #200
City, State, Zip	EVERETT, WA 98208
Country	US
FDA Owner/Operator Phone	425-379-2580
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 TEST KIT
FDA Proprietary Device Name	DBEST AFP TEST KIT
FDA Owner / Operator Number	9002732
FDA Owner / Operator Name	AMERITEK USA, INC.
FDA Establishment Registration Number	3025672
FDA Registered Establishment Name	AMERITEK USA, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-04-00
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	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
2	GENETIC TECHNOLOGIES INC. 6157 N.W. 167TH ST., F-26 MIAMI, FL 33015 US 305-828-3818 / 305-828-3818	GTI-AFP MICROPLATE ELISA	AFP ELISA
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