LabGenomics Receives MFDS Approval for Ovulation and Pregnancy Test Kits 'D-Day Check' and 'Wonder Baby Check'

Labgenomics announced on the 15th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its new products for ovulation and pregnancy diagnosis, 'D-Day Check' and 'Wonder Baby Check.'

Both products are personal in vitro diagnostic medical devices that help confirm ovulation days and pregnancy status. They use an immunochromatographic assay to qualitatively measure luteinizing hormone (LH) and human chorionic gonadotropin (hCG) in urine. After dipping a urine sample into the specimen absorption area, results can be confirmed within 5 minutes, and the devices are highly portable for convenient use.

'D-Day Check' helps predict ovulation days and identify periods with a high likelihood of pregnancy to assist in planning conception. It increases prediction accuracy by detecting the 'LH surge,' the point at which luteinizing hormone secretion rapidly increases. 'Wonder Baby Check' measures human chorionic gonadotropin to confirm pregnancy and supports users in systematic pregnancy management.

In particular, Labgenomics guarantees excellent discrimination and accuracy of the products by using World Health Organization (WHO) international standard materials. Users are expected to accurately monitor their condition even during the early stages of pregnancy, including 3 to 4 days before and after the expected ovulation date.

A company representative stated, “Both products can be conveniently purchased through online platforms as well as offline stores such as clinics, pharmacies, and health & beauty (H&B) stores. We will strive to enhance product accessibility and convenience to enable high-quality health management and family planning.”