Zdrowie i gospodarka · 16/08/2024

FDA Classifies Device for Detecting SARS-CoV-2 and Other Microbial Agents

The FDA has classified a device that detects and identifies nucleic acid targets in respiratory specimens from SARS-CoV-2 and other microbial agents into Class II, requiring special controls to ensure safety and effectiveness.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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