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U.S. Department of Health and Human Services

Product Classification

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Device anaplasma spp. and ehrlichia spp. serological reagents
Definition Tests or reagents used to detect IgG and/or IgM antibodies to Anaplasma spp. and/or Ehrlichia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Anaplasma spp. and/or Ehrlichia 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 Anaplasma spp. and/or Ehrlichia spp.
Review Panel Microbiology
Product CodeQIO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
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