Product Classification

• Device: orientia spp. (scrub typhus) serological reagents
• Definition: Tests or reagents used to detect IgG and/or IgM antibodies to Orientia spp. (Scrub Typhus) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Orientia spp. in patients suspected of exposure.
• Physical State: Capture antigen substrates (e.g., slides, plates, strips), secondary reagents/conjugates, positive/negative controls, sample diluents, buffers, and media.
• Technical Method: Target antibodies are captured by antigen preparations and detected with secondary reagents/conjugates.
• Target Area: IgG and/or IgM antibodies to Orientia spp.
• Review Panel: Microbiology
• Product Code: QIQ
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Not Classified Reason: For Export Only
• Submission Type: Contact ODE
• 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