Pure Global

Brain Trauma Assessment Test

Brain Trauma Assessment Test is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Brain Trauma Assessment Test
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QAT

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Class 2

21 CFR 866.5830

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Immunology

Device Characteristics

No

No

No

Eligible

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