The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing.
Source: The GMP Letter
The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing.
Source: The GMP Letter