Product code DAR

Device name

Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control

Medical specialty

Hematology

Device class

2

Regulation number

864.7340

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Source

FDA openFDA device classification dataset