Product code QHR

Device name

Blood Grouping Reagent

Medical specialty

Hematology

Device class

U

Regulation number

660.20

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

For red blood cell antigen typing

Source

FDA openFDA device classification dataset