Access Bio is in the process of seeking Emergency Use Authorisation (EUA) for the product from the US Food &
Drug Administration (US FDA) with approval anticipated in Q2 FY21.
DIVOC Labs has committed to an initial order of 77,000 units which will become effective upon receipt by DIVOC of regulatory approval of the product for professional use in India. This process is underway with AtomoRapidTM COVID-19 sample tests already in country and undergoing evaluation to support the regulatory process. Regulatory approval is anticipated to be received in Q2 FY21.
Found these from the last quarterly, seems we are a bit behind from the anticipated approval date.
Access Bio is in the process of seeking Emergency Use...
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