Does read as though the approval covers the sales to 'professional or self test use' 'but I don't know enough about the regulatory structure of the NZ medical device approvals market. TBH I wasn't even aware we made an application to the TGA equivalent in NZ lol.
Though, reading over the announcement of the AccessBio renegotiated supply agreement it does indicate that AT1 has a right to only sell the POC (professional use) RAT in Aus and NZ. This right is not extended to the sales of the 10million self-use tests in the NZ market. See below
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