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精选法规与标准美国 FDAT1085

Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples

·26 天前·来源:美国 FDA

🤖 AI 摘要

The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples 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 simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples. We

分析模型:rule-based-v3 · 07-09 06:59

评分详情

综合分 85/100

信源权威

95

影响范围

90

时效性

50

合规紧急

75

行业关注

90

Federal Register: FDA Final Rules (最终法规)
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