Product code PQO

Device name

Anti-Müllerian Hormone Test System

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1092

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset