FDA Registration
Active
🇺🇸 United States
KINGSWAY PHARMACEUTICALS DBA NFI, LLC
Reg #: 3013167221
·
FEI: 3013167221
·
Expires 2026
Products
6
Proprietary Names
13
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- KINGSWAY PHARMACEUTICALS DBA NFI, LLC
- Registration Number
- 3013167221
- FEI Number
- 3013167221
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 636 Shelby Street, Suite 300
- City
- Bristol
- State
- TN
- ZIP
- 37620
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180771
Owner / Operator
- Firm Name
- Kingsway Pharmaceuticals dba NFI, LLC
- Operator Number
- 10053911
- Address
- 636 Shelby Street, Suite 300
- City
- Bristol
- State
- TN
- Postal Code
- 37620
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2025-09-26 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2025-12-09 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2025-12-09 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2026-03-03 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2026-03-03 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2025-12-09 |
Proprietary Names
e.p.t. 3ct Menopause
SureSign 2ct Menopause (FSH) Test
e.p.t. 2ct Pregnancy Test
SureSign 10Lh + 25mIU Ovulation and Pregnancy Test
SureSign 5ct 25mIU Single Step Pregnancy Test
Goodline Ingrown Hair and Nick Patch
Bikini Zone Ingrown Hair Patch
Equate 6 Days Sooner 50ct Pregnancy Strips
SureSign 5ct 10mIU 6 Day Early Pregnancy Test
SureSign 5ct UTI
e.p.t 3ct UTI
SureSign 20ct LH Digital Ovulation Test
SureSign 3ct Digital 25mIU Pregnancy Test
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198