Product Classification

• 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 Code: QTQ
• 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