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Lateral flow device

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Guest user Created:   Jul 05, 2021 Last commented:   Jul 08, 2021

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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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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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:

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Jul 05, 2021

Jul 08, 2021