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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay, direct, nucleic acid amplification, respiratory syncytial virus
Regulation Description Respiratory syncytial virus serological reagents.
Definition These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial 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.
Product CodeNHY
Regulation Number 866.3480
Device Class 1