Reagents For Detection Of Norovirus Nucleic Acid

PIQ · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3990

Classification

FDA Product Code: PIQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3990
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

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