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GoldN Easy to Use Vaginal pH Test

NOVODX Corporation · Model GN041ST01-US · UDI-DI 00850059915882

510(k) clearances

Adverse events

Recalls

Facilities

Description

The GoldN™ Easy to Use Vaginal pH Test is a fast pH value test of vaginal fluid specimens. The test is semi-quantitative for determination of vaginal pH range. It is designed for self-testing and in vitro diagnostic use to see if the vagina is under normal stage. The test is for use as an aid in the diagnosis of bacterial vaginosis. The intended population is women of menstruating age. It is intended for use by women who have any of the following symptoms: vaginal itching, vaginal burning or an abnormal color, odor, or excessive amount of vaginal discharge.

Recalls

Date	Firm	Reason
2026-04-02	DFI Co., Ltd.	The devices were distributed without required FDA premarket clearance or approval.
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.
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri

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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.