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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device brain trauma assessment test
Definition Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care
Product CodeQAT
Regulation Number 866.5830
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 3
ABBOTT POINT OF CARE
  SUBSTANTIALLY EQUIVALENT 1

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