Business · 09/10/2009
FDA Releases Guidance Documents for Respiratory Viral Panel Multiplex Nucleic Acid Assay
The Food and Drug Administration (FDA) has released guidance documents for the Respiratory Viral Panel Multiplex Nucleic Acid Assay, a Class II medical device, to ensure compliance with special controls. The documents provide recommendations for performance evaluation, labeling, and addressing the impact of ancillary reagents on the device's safety and effectiveness.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →