FDA Registration
Active
🇺🇸 United States
NOVODX Corporation
Reg #: 3030230672
·
FEI: 3030230672
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- NOVODX Corporation
- Registration Number
- 3030230672
- FEI Number
- 3030230672
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 110 Front St Ste 300
- City
- Jupiter
- State
- FL
- ZIP
- 33477
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233174
Owner / Operator
- Firm Name
- NOVODX Corporation
- Operator Number
- 10089550
- Address
- 1061 E Indiantown Road, Suite 110
- City
- Jupiter
- State
- FL
- Postal Code
- 33477
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2025-01-07 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2023-12-29 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2023-12-29 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2025-01-07 |
Proprietary Names
GoldN Easy to Use Pregnancy Test
GoldN Easy to Use Ovulation Test
GoldN Easy to Use FSH Test
GoldN Easy to Use Vaginal pH Test
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198