OMS · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3332
Classification
FDA Product Code
OMS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3332
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein aids in the diagnosis of influenza caused by novel influenza A viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza A viruses and provide epidemiological information on influenza.