Product code QUD

Device name

Blood Detection Capsule

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1390

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract.

Source

FDA openFDA device classification dataset