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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BD ProbeTec CTB Kit; BD ProbeTec CTB, DTB, M. Kansasii; BD ProbeTec DTB kit; BD ProbeTec DTB Oven; BD ProbeTec DTB Reagent Pack; BD ProbeTec DTB Sonic Bath; BD ProbeTec M. kansasii ID Kit; BD ProbeTec Sample Processing kit
Classification Name: SYSTEM, NUCLEIC ACID AMPLIFICATION, MYCOBACTERIUM TUBERCULOSIS COMPLEX
Product Code: MWA
Device Class: 2
Regulation Number: 866.3372
Medical Specialty: Microbiology
Registered Establishment Name: BECTON, DICKINSON & CO.
Registered Establishment Number: 1119779
Owner/Operator: BECTON, DICKINSON & CO.
Owner/Operator Number: 9922032
Establishment Operations: U.S. Manufacturer of Export Only Devices
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