Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Novel Influenza A Virus, A/H5 Ns1 Protein

FDA product code OMS · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3332
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-04-08 – 2009-04-08

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.

↑