Product Classification

• Device: rickettsia spp. (spotted fever group or typhus group) serological reagents
• Definition: Tests or reagents used to detect IgG and/or IgM antibodies to Ricketsia spp. (Spotted Fever Group or Typhus Group) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Ricketsia 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 Ricketsia spp.
• Review Panel: Microbiology
• Product Code: QIP
• Premarket Review: Division of Microbiology Devices (DMD); 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