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U.S. Department of Health and Human Services

Product Classification

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Device assay, direct, nucleic acid amplification, parainfluenza virus
Regulation Description Parainfluenza virus serological reagents.
Definition These reagents are nucleic acid primers and probes for the amplification and identification of Parainfluenza 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 CodeNHZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3400
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons