Multi-Analyte Respiratory Virus Antigen Detection Test
SCA · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3987
Classification
FDA Product Code
SCA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3987
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.