Product code QIP
- Device name
- Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset