QIO — Anaplasma Spp. And Ehrlichia Spp. Serological Reagents Class N
FDA product code QIO covers "Anaplasma Spp. And Ehrlichia Spp. Serological Reagents", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QIO
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
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.