TriVerity
Inflammatix, Inc. is listed for TriVerity (K241676). The FDA list gives January 10, 2025 as the date of the final decision. The lead panel is Microbiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PRE as “Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers”: A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241676
- Date of final decision
- January 10, 2025
- Company on the FDA list
- Inflammatix, Inc.
- Lead panel
- Microbiology
- Primary product code
- PRE
- openFDA device name for the code
- Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
- Device class
- 2
- Regulation number
- 866.3215
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary
Product-code text from openFDA
A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.