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The sofia 2 flu + sars antigen fia is intended for use on the sofia 2 only and by medical professionals or trained operators who are proficient in performing tests using the sofia 2. Sofia 2 is designed to provide safe and reliable operation when used according to this user manual. The sofia sars antigen fia is intended for use by medical professionals or trained operators who are proficient in performing tests using the sofia and sofia 2 instrument.
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The sofia sars antigen fia test is only for in vitro diagnostic use under the food and drug administration’s emergency use authorization
This product has not been fda cleared or approved. Sofia 2 has been designed to cispr 11 class a
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