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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BreathTek UBT for H.pylori and pediatric urea hydrolysis rate calculation application (pUHR-CA)
Classification Name: TEST, UREA ADULT AND PEDIATRIC (BREATH),
Product Code: OZA
Device Class: 3
Regulation Number: 866.3110
Medical Specialty: Microbiology
Registered Establishment Name: OTSUKA AMERICA PHARMACEUTICAL, INC.
Registered Establishment Number: 3000718406
Owner/Operator: OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC
Owner/Operator Number: 9107159
Establishment Operations: Specification Developer; Complaint File Establishment
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