Product code QAT

Device name

Brain Trauma Assessment Test

Medical specialty

Immunology

Device class

2

Regulation number

866.5830

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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

Source

FDA openFDA device classification dataset