QUD

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Blood Detection Capsule

Device class

Class II (moderate risk)

Regulation

21 CFR 876.1390

Medical specialty

Gastroenterology, Urology

FDA 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.

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