Blood Detection Capsule

QUD · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1390

Classification

FDA Product Code: QUD
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.1390
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown