PRE — Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers Class II

FDA Device Classification

Classification Details

Product Code
PRE
Device Class
Class II
Regulation Number
866.3215
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241676inflammatixTriVerityJanuary 10, 2025
K232095immunexpressSeptiCyte RAPIDDecember 15, 2023
K203748immunexpressSeptiCyte RAPIDNovember 29, 2021
K163260immunexpressSeptiCyte LABFebruary 17, 2017