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Device assay, direct, nucleic acid amplification, influenza virus
Regulation Description Influenza virus serological reagents.
Definition These reagents are nucleic acid primers and probes for the amplification and identification of influenza virus directly from clinical specimens.The identification aids in the diagnosis of influenza and provides epidemiological information on this disease.This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNIA
Submission Type 510(k)
Regulation Number 866.3330
Device Class 1
GMP Exempt? No
Third Party Review Not Third Party Eligible
 
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