Product code QDH

Device name

Menopause Test System

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1093

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women.

Source

FDA openFDA device classification dataset