QUD

Blood Detection Capsule

Product code

QUD

Device name

Blood Detection Capsule

Device class

Class 2

21 CFR

21 CFR 876.1390

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).