Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 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 CodeQIP
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
-
-