Norovirus Serological Reagent

OUC · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3395

Classification

FDA Product Code: OUC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3395
Review panel: MI
Medical specialty: Microbiology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in individuals with signs and/or symptoms of acute gastroenteritis, or in the determining the etiology of acute gastroenteritis outbreaks.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 5

Source

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