Product code GMO

Device name

Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.

Medical specialty

Microbiology

Device class

2

Regulation number

866.3220

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset