Anti-Müllerian Hormone Test System

PQO · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1092

Classification

FDA Product Code: PQO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1092
Review panel: TX
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 9

Source

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