Business · 22/11/2000Updated: 10/17/2026 · 1 min read

FDA Classifies Anti-Saccharomyces cerevisiae (ASCA) Test System Under Special Controls

Summary

The FDA has classified the Anti-Saccharomyces cerevisiae (ASCA) test system into Class II, requiring a special control guidance document to ensure the safety and effectiveness of the device, in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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