Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

PRE · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215

Classification

FDA Product Code: PRE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3215
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown