510(k) K240279

VIDAS TBI (GFAP, UCH-L1) by bioMerieux, Inc. — Product Code QAT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 1, 2024
Date Received: February 1, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Brain Trauma Assessment Test
Device Class: Class II
Regulation Number: 866.5830
Review Panel: IM
Submission Type

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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510(k) K240279

Clearance Details

Device Classification

Other clearances by bioMerieux, Inc.

Other clearances for product code QAT