Galectin-3 In Vitro Diagnostic Assay

OSX · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1117

Classification

FDA Product Code: OSX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1117
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 4

Source

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