QAT

Brain Trauma Assessment Test

Product code

QAT

Device name

Brain Trauma Assessment Test

Device class

Class 2

21 CFR

21 CFR 866.5830

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2024-05-01.

3 summaries are archived here for direct download.