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Brain Trauma Assessment Test

FDA product code QAT · 5 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5830
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2021-01-08 – 2024-05-01

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

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