Product code JBI

Device name

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition

Medical specialty

Hematology

Device class

2

Regulation number

864.7360

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset