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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device to detect microbial colonization directly from clinical specimens.
Definition A device to detect microbial colonization directly from clinical specimens is a qualitative in vitro diagnostic device intended for the detection and identification of microbial-associated targets from patients who are suspected of being colonized with a microbial pathogen and may present a risk of transmission to other patients and health care workers. This device is intended to aid in the detection of microbial colonizers for the prevention and control of infection in healthcare settings when used in conjunction with clinical and laboratory findings.
Product CodeSBT
Regulation Number 866.3967
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN MOLECULAR LLC
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