Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (DHN) (1) Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use (PIV) (1)