Emergency_medicine
TriVerity
Inflammatix, Inc.
FDA
FDA-cleared AI medical device
In-vitro diagnostic test that measures host-response gene expression from whole blood to produce scores for bacterial infection, viral infection, and illness severity, intended as an aid in assessing adults with suspected acute infection or sepsis in the emergency department.
FDA Submission Metadata
- Submission number
- K241676
- Decision date
- January 2025
- FDA panel
- Microbiology
- Product code
- PRE
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA