I can not imagine TGA having a typo on that type of statement lasting too long. this is from the EUA FDA notice
Document Revision Information
Doc Rev. 8.0
09/2021
Added the following statement to the Procedural limitations section: The performance of this test was
established based on the evaluation of a limited number of clinical specimens
You would hope our new man ex Abbot would know a thing or 2 about/rumours of the opposition Roche device.
EuGeni, page-2007
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