DBEST H.PYLORI-URESA 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	MI - Microbiology
FDA Product Code	MSQ
FDA Classification Name	TEST, UREA (BREATH OR BLOOD)
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3110
FDA Common Generic Name	H.PYLORI-URESA TEST KIT
FDA Proprietary Device Name	DBEST H.PYLORI-URESA 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	BREATHID 2006 7 HAMARPE ST JERUSALEM, 97774 IS 972-258-99120 / 972-258-99120	BREATHID SYSTEM	BREATHTEST SYSTEM
2	HERITAGE LABS INTL., LLC 1111 WEST OLD 56 HWY. OLATHE, KS 66061 US / 913-764-1045	TEST, UREA (BREATH OR BLOOD)	BREATKEK-UBIT UBT FOR H. PYLORI
3	ISODIAGNOSTIKA INC 17215-108 AVE EDMONTON, ALBERTA, T5S 1G2 CA 780-487-1600 / 780-487-1500	HELIKIT	13 C-UREA BREATH TEST
4	ISOMED, S.L. 46 ALBERTO ALCOCER MADRID, 28016 SP 003-491-3440655 / 003-491-3440655	TAU-KIT	TAU-KIT
5	METABOLIC SOLUTIONS, INC. 460 AMHERST ST. NASHUA, NH 03063 US 603-598-6960 / 603-598-6960	EX-HBT (13C UREA BLOOD TEST)	13C UREA BLOOD TEST
6	OTSUKA AMERICA PHARMACEUTICAL, INC. 2440 RESEARCH BLVD. ROCKVILLE, MD 20850 US 301-990-0030 / 240-683-3569	BREATHTEK UBT FOR HELICOBACTER PYLORI	BREATH TEST FOR HELICOBACTER PYLORI
7	OTSUKA ELECTRONICS CO., LTD. 3-26-3, SHODAI-TAJIKA,HIRAKATA OSAKA, 573-1132 JA 81-3-32920021 / 81-36-3617311	UBIT-IR300 INFRARED SPECTROMETRY SYSTEM	INFRARED SPECTROMETRY SYSTEM