OMS · Class II · 21 CFR 866.3332

FDA Product Code OMS: Novel Influenza A Virus, A/h5 Ns1 Protein

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.

1
Total
1
Cleared
152d
Avg days
2009
Since

FDA 510(k) Cleared Novel Influenza A Virus, A/h5 Ns1 Protein Devices (Product Code OMS)

1 devices
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No devices found for this product code.

About Product Code OMS - Regulatory Context