Anaplasma Spp. And Ehrlichia Spp. Serological Reagents
QIO · Not classified · Unknown
Classification
FDA Product Code
QIO
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 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.