Chromogranin A

QXS · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6010

Classification

FDA Product Code: QXS
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.6010
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

In vitro test to measure Chromogranin A (CgA) as an aid in monitoring during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors.

Market data

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

Source

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