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U.S. Department of Health and Human Services

Product Classification
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Device reagents, monkeypox virus nucleic acid.
Definition Nucleic acid-based in vitro diagnostic devices for the detection of monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens
Physical State In Vitro Diagnostic Device including Primers, Probes and/or capture oligos
Technical Method Nucleic acid amplification and/or detection
Target Area The device is an in-vitro diagnostic device used on clinical specimens; none of the body parts will utilize the device or are intended to be affected by the device.
Review Panel Microbiology
Product CodeQTP
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
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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