• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device reagents, non-variola orthopoxvirus nucleic acid.
Definition Nucleic acid-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus 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 CodeQTQ
Premarket Review Division of Microbiology Devices (DMD)
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
-
-