QIP — Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents Class N
FDA product code QIP covers "Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QIP
- 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 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.