NXD · Class II · 21 CFR 866.3332

FDA Product Code NXD: Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna

Novel Influenza A Virus Reagents Are Used In Nucleic Acid Amplification Tests To Directly Detect And Differentiate Novel Influenza A Virus Specific Rna Gene Segments In Human Respiratory Specimens Or Viral Cultures. Detection And Differentiation Of Specific Rna Gene Segments 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. These Reagents Are Primers And Probes, Along With A Specific Novel Influenza Virus Control.

3
Total
2
Cleared
126d
Avg days
2006
Since

FDA 510(k) Cleared Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna Devices (Product Code NXD)

3 devices
1–3 of 3
No devices found for this product code.

About Product Code NXD - Regulatory Context