Identity
- Trade Name
- GoldN Easy to Use Ovulation Test FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The GoldNTM Easy to Use Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of Luteinizing Hormone (LH) surge in urine to predict the time of ovulation. The test is intended for women who want to conceive. For in vitro diagnostic use. For over-the-counter use. FDA UDI
- Model / Reference
- GN013ST10-US FDA UDI
- Description
- The GoldNTM Easy to Use Ovulation Test is a rapid chromatographic immunoassay for the qualitative detection of Luteinizing Hormone (LH) surge in urine to predict the time of ovulation. The test is intended for women who want to conceive. For in vitro diagnostic use. For over-the-counter use. FDA UDI
Identifiers
- Catalog Number
- GN013ST FDA UDI
- Primary DI / UDI-DI
- 00850059915646 FDA UDI
- FDA Product Code
- NGE FDA UDI
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1485 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
GoldN Easy to Use Ovulation Test by NOVODX Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical.
- AMPLIM — AMPLIM, LLC · Class II
- Natalist Ovulation Test — Equinox Biotech Co., Ltd. · Class I
- AMPLIM — AMPLIM, LLC · Class II
- INSTANT-VIEW LH Ovulation Predicting Cassette Test — Alfa Scientific Designs, Inc. · Class I
- Mosie Baby Ovulation Test — GERMAINE LABORATORIES, INC. · Class I
- FERTICARE — Weihai Kangzhou Biotechnology Engineering Co., Ltd · Class I
- Modern Fertility Ovulation Test — MODERN HEALTH · Class I
- Natural Cycles — Natural Cycles Nordic AB · Class II
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 |
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Manufacturer
- Manufacturer
- NOVODX Corporation
Sources (1)
- FDA UDI 91a39451-ea83-43c9-9aa2-48cd289f7ea8 35 fields · synced Jun 6, 2026