Identity
- Trade Name
- GoldN Easy to Use Vaginal pH Test FDA UDI
- Generic Name
- Vaginal pH screening IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- GN041ST01-US FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- GN041ST FDA UDI
- Primary DI / UDI-DI
- 00850059915882 FDA UDI
- FDA Product Code
- CEN FDA UDI
- GMDN Term
- Vaginal pH screening IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vaginal pH screening IVD, kit, rapid colorimetric, clinical
GoldN Easy to Use Vaginal pH Test by NOVODX Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal pH screening IVD, kit, rapid colorimetric, clinical.
- VS-SENSE OTC — PEPTONIC MEDICAL ISRAEL LTD · Class I
- Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- VS-SENSE — PEPTONIC MEDICAL ISRAEL LTD · Class I
- Exploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- Testahead Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- Exploro Vaginal Health pH Test Device — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
- Clinistix Vaginal Health Test — PEPTONIC MEDICAL ISRAEL LTD · Class I
- Safecare Vaginal PH Rapid Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NOVODX Corporation
Sources (1)
- FDA UDI 1e7c1782-0d2d-4cdd-9520-482e7c99b9a9 35 fields · synced May 30, 2026