QKE

Immunoassay, Pregnanediol Glucuronide, Over The Counter

Product code

QKE

Device name

Immunoassay, Pregnanediol Glucuronide, Over The Counter

Device class

Class 1

21 CFR

21 CFR 862.1620

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation

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