ISO 13485 & EU MDR / Lateral flow device
i am trying to find out what a lateral flow device using saliva would come under with the FDA class 1 or class 2
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According to my knowledge, it is under FDA the class 1. But, please take that with a grain of salt. Namely, we are not authorized to define the classification of medical devices.
Definitions for classification can be found on the following link: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
For more information regarding fulfilling FDA regulatory classes for medical devices, please see following link:
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