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Surearly SMART Menopause Test

Sugentech Inc._Osong Branch · Model Surearly SMART Menopause Test · UDI-DI 08809408863475

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Surearly SMART Menopause Test works by inserting the test stick into the Test reader, which measures color changes on the test stick. It detects FSH at a concentration of 25 mIU/mL or greater. The test line utilizes a monoclonal FSH antibody and the test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, FSH combines with antibody gold conjugates on the gold conjugate pad. The formed antigen-antibody complexes react with the anti-FSH antibody on the test line, resulting in red or purple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, the Surearly SMART Menopause Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graphs and additional messages to help your comprehensive management of hormonal health.

Recalls

Date	Firm	Reason
2025-11-22	Changchun Wancheng Bio-Electron Co., Ltd.	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.