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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY. 510(k) Number: K162642 B. Purpose for Submission: New device C. Measured: Influenza A and B virus nucleoprotein antigens in nasal and
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Influenza A and B are two different types of the influenza virus that can cause seasonal flu outbreaks.
Healthcare providers and laboratories are required to report cases of influenza A and B to public health authorities.
Healthcare providers can fill out a report on influenza A and B by documenting the patient's symptoms, test results, and any other relevant information.
The purpose of reporting influenza A and B is to track and monitor the spread of the virus in order to implement appropriate public health measures.
Information such as the patient's symptoms, test results, age, gender, and vaccination status must be reported on influenza A and B.
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