Product code QHT

Device name

Reagent Red Blood Cells

Medical specialty

Hematology

Device class

U

Regulation number

660.30

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

For the detection of or identification of human blood-group antibodies

Source

FDA openFDA device classification dataset