FDA Registration
Active
🇺🇸 United States
GoldN Easy to Use Pregnancy Test
Reg #: 3030230672
·
FEI: 3030230672
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- NOVODX Corporation
- Registration Number
- 3030230672
- FEI Number
- 3030230672
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1061 E Indiantown Rd Ste 110
- 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 |
Proprietary Names
GoldN Easy to Use Pregnancy Test
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility