Product code PIQ

Device name

Reagents For Detection Of Norovirus Nucleic Acid

Medical specialty

Microbiology

Device class

2

Regulation number

866.3990

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset