Product code QHS

Device name

Anti-Human Globulin

Medical specialty

Hematology

Device class

U

Regulation number

660.50

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology

Source

FDA openFDA device classification dataset