← Back to catalogue
GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC) FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A rapid immunochromatographic assay for the qualitative detection of Luteinizing Hormone (LH) surge for the detection of ovulation and fertility. For over-the-counter use. The test reagent is exposed to urine, allowing urine to migrate through the absorbent test strip. The labeled antibody-dye conjugate binds to the LH in the specimen forming an antibody-antigen complex. This complex binds to the anti-LH antibody in the test region (T) and produces a colored line. In the absence of LH, there is no color line in the test region (T). The reaction mixture continues flowing through the absorbent device past the test region (T) and control region (C), producing a colored line, demonstrating that the test strip is functioning correctly. The test strip can accurately detect your LH surge when the concentration of LH is equal to or greater than 25mIU/ml. FDA UDI
- Model / Reference
- GN013ST FDA UDI
- Description
- A rapid immunochromatographic assay for the qualitative detection of Luteinizing Hormone (LH) surge for the detection of ovulation and fertility. For over-the-counter use. The test reagent is exposed to urine, allowing urine to migrate through the absorbent test strip. The labeled antibody-dye conjugate binds to the LH in the specimen forming an antibody-antigen complex. This complex binds to the anti-LH antibody in the test region (T) and produces a colored line. In the absence of LH, there is no color line in the test region (T). The reaction mixture continues flowing through the absorbent device past the test region (T) and control region (C), producing a colored line, demonstrating that the test strip is functioning correctly. The test strip can accurately detect your LH surge when the concentration of LH is equal to or greater than 25mIU/ml. FDA UDI
Identifiers
- Catalog Number
- GN013ST25-US FDA UDI
- Primary DI / UDI-DI
- 00850059915424 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
- Not 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
GoldN LH Ovulation Rapid Test Midstream (Urine)(25-Pack) (OTC) by NOVODX Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 2c53a299-a793-435f-94db-eebe028c84cc 36 fields · synced Jun 8, 2026