PQO

Anti-Müllerian Hormone Test System

Product code: PQO
Device name: Anti-Müllerian Hormone Test System
Device class: Class 2
21 CFR: 21 CFR 862.1092
Medical specialty: Clinical Chemistry
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 5 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PQO

Classification and pathway per current FDA publications. Data from openFDA (CC0).