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Lyophilized AOD9604 is typically reconstituted with bacteriostatic water

doi: 10.1038/s41573-021-00339-6 13 WangJWongYKLiaoF

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However, manufacturers must first determine device classification, which is grouped into three groups based on the overall risk level: Class I for low-risk devices Class II for devices with moderate risk Class III for devices with the highest risk Determining your device classification will help manufacturers determine the ideal pathway for a regulatory submission

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