QDH

Menopause Test System

Product code

QDH

Device name

Menopause Test System

Device class

Class 2

21 CFR

21 CFR 862.1093

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

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