Immunoassay, Pregnanediol Glucuronide, Over the Counter

Who Makes This Device Type in China?

4 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Assure Tech. (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Guangzhou Wondfo Biotech Co., Ltd. Guangdong, contract manufacturer
Guangzhou Decheng Biotechnology Co., Ltd. Guangdong
Hangzhou Careomedic Tech Co., Ltd. Zhejiang, contract manufacturer

What Is It?

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

What Is FDA Product Code QKE?

Immunoassay, Pregnanediol Glucuronide, Over The Counter is FDA product code QKE, Class 1, 21 CFR 862.1620.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Immunoassay, Pregnanediol Glucuronide, Over The Counter

Eli Progesterone Hormometer™

Eli Progesterone Hormometer™ Hormone Test 4 Count

Immunoassay, Pregnanediol Glucuronide, Over The Counter

GenaCheck®PdG At-Home Ovulation Confirmation Test

GenaCheck®PdG At-Home Ovulation Confirmation Test: 1 catalogue number listed by Genabio Diagnostics Inc, United States, under Immunoassay, Pregnanediol Glucuronide, Over The Counter. 4 manufacturers in China are registered for this product code.

Immunoassay, Pregnanediol Glucuronide, Over The Counter

One Step® Progesterone (PdG) Urine Test Strip

PdG strip pack of 6

Immunoassay, Pregnanediol Glucuronide, Over The Counter

Proov

A comprehensive screening kit that analyzes key hormone factors related to fertility. Contains 3 FSH urine tests to check ovarian reserve, 10 LH tests to predict ovulation during the…

Immunoassay, Pregnanediol Glucuronide, Over The Counter