BREATHTEK UBT FOR HELICOBACTER PYLORI MANUFACTURED BY OTSUKA AMERICA PHARMACEUTICAL, INC.

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Request for Information Form	Contact Information
Company Name	OTSUKA AMERICA PHARMACEUTICAL, INC.
Address	2440 RESEARCH BLVD.
City, State, Zip	ROCKVILLE, MD 20850
Country	US
FDA Owner/Operator Phone	301-990-0030
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	BREATH TEST FOR HELICOBACTER PYLORI
FDA Proprietary Device Name	BREATHTEK UBT FOR HELICOBACTER PYLORI
FDA Owner / Operator Number	9107159
FDA Owner / Operator Name	OTSUKA AMERICA PHARMACEUTICAL, INC.
FDA Establishment Registration Number	134297
FDA Registered Establishment Name	OTSUKA AMERICA PHARMACEUTICAL, INC.
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	09-05-07
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 H.PYLORI-URESA TEST KIT	H.PYLORI-URESA TEST KIT
2	BREATHID 2006 7 HAMARPE ST JERUSALEM, 97774 IS 972-258-99120 / 972-258-99120	BREATHID SYSTEM	BREATHTEST SYSTEM
3	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
4	ISODIAGNOSTIKA INC 17215-108 AVE EDMONTON, ALBERTA, T5S 1G2 CA 780-487-1600 / 780-487-1500	HELIKIT	13 C-UREA BREATH TEST
5	ISOMED, S.L. 46 ALBERTO ALCOCER MADRID, 28016 SP 003-491-3440655 / 003-491-3440655	TAU-KIT	TAU-KIT
6	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
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