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U.S. Department of Health and Human Services

Product Classification

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Device non-variola orthopoxvirus real-time pcr primer and probe set
Definition In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Physical State Provided in the device are Non-variola Orthopoxvirus Real-time PCR Assay Reagents which include primers and probes, positive controls, and an extraction control.
Technical Method A Non-variola Orthopoxvirus Real-time PCR Assay method which includes nucleic acid isolation, amplification and detection of nucleic acid using a PCR instrument. A set of primers and probes are used for the in vitro detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Target Area Human Clinical Samples (e.g., pustular or vesicular rash specimens) and viral cell culture lysates
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePBK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3315
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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