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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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Kristina Zvonar Brkić
Jul 08, 2021
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:
- How to use ISO 13485 to fulfill FDA regulatory classes for medical devices https://advisera.com/13485academy/blog/2017/09/14/how-to-use-iso-13485-to-fulfill-fda-regulatory-classes-for-medical-devices/
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Jul 08, 2021
Jul 08, 2021