Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
QIP · Not classified · Unknown
Classification
FDA Product Code
QIP
Device class
Not classified
Regulation
—
Review panel
MI
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.