Multiplex Nucleic Acid Detection System For Biothreat Agents

QVR · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.4000

Classification

FDA Product Code: QVR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.4000
Review panel: MI
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

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