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U.S. Department of Health and Human Services

Product Classification

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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.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNHY
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3480
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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