On Friday, IDL Biotech announced that it have recieved feedback from the FDA regarding its pre-submission request. It is now confimed IDL will pursue the 510k route in order to reach approval for UBC Rapid in the US market. We have a positive view on the news, as IDL has to show that UBC Rapid is "substantially equivalent" to a predicate device already approved by the FDA (most probably NMP22).

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