Sofia 2- RSV waived vs moderately complex age

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Does anyone know the reasoning behind why a moderately complex license can run ages  7 to less than 19 years of age and a waived license can only do under the age of 7? 

Thanks,

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Maybe the manufacturer has a better answer as it relates to their FDA Approval process.

Sincerely,
Alma
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Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
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Per Technical Support they say it is because the studies they performed were for children under 7 so the waived licenses need to use that age restriction.


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