Product code NTY

Device name

System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

Medical specialty

Immunology

Device class

2

Regulation number

866.6010

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.

Source

FDA openFDA device classification dataset