Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test

🤖 AI 摘要

The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the SARS- CoV-2 serology test. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also e

分析模型：rule-based-v3 · 07-09 06:59