FDA UDI
In Commercial Distribution
🇺🇸 United States
GoldN Easy to Use FSH Test
DI: 00850059915370
·
Model: GN011ST02-US
·
NOVODX Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GoldN Easy to Use FSH Test
- Primary DI
- 00850059915370
- Version / Model
- GN011ST02-US
- Catalog Number
- GN011ST
- Company Name
- NOVODX Corporation
- Labeler DUNS
- 119046376
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-24
- Public Version
- 2
- Public Version Date
- 2025-11-06
- Public Version Status
- Update
- Public Device Record Key
- 114f261a-6bb5-49f0-bac9-97726bc940e1
Device Description
The GoldN™ Easy to Use FSH Test is a rapid immunochromatographic assay for the qualitative detection of follicle-stimulating hormone (FSH) in urine to aid women in the assessment of the onset of menopause.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Clinical Chemistry | 862.1300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65841 | Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of follicle stimulating hormone (FSH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment as an aid in the diagnosis of conditions related to reproductive health (e.g., menopause, infertility). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850059915370 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 30 Degrees Fahrenheit