510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QIONot classified

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

Unknown
FDA source (opens on fda.gov)

QIO is the FDA product code for Anaplasma Spp. And Ehrlichia Spp. Serological Reagents. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QIO
Device name
Anaplasma Spp. And Ehrlichia Spp. Serological Reagents
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
Contact ODE
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code