Zdrowie i gospodarka · 23/03/2005

FDA Classifies Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems as Class II Devices with Special Controls

The US Food and Drug Administration (FDA) has classified automated fluorescence in situ hybridization (FISH) enumeration systems as Class II devices with special controls, aiming to ensure the safety and effectiveness of these medical devices, as outlined in the new guidance document 'Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems'.