Business · 22/06/2026

FDA Classifies Simple In Vitro Diagnostic Device for Detection of Secreted Proteins from Bacillus Species in Human Clinical Samples

The FDA has classified a simple in vitro diagnostic device for detecting secreted proteins from Bacillus species in human clinical samples into Class II, a move aimed at ensuring the device's safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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