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U.S. Department of Health and Human Services

Product Classification
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Device reagents, non-variola orthopoxvirus or monkeypox virus singleplex antigen tests
Definition Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY
Physical State In Vitro Diagnostic device
Technical Method Antigen 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 CodeQTU
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Not Classified Reason For Export Only
Submission Type Enforcement Discretion
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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