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
Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
Kit, Test, Pregnancy, Hcg, Over The Counter LCX
Dressing, Wound, Hydrophilic NAC
Test, Urine Leukocyte LJX
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
Test, Luteinizing Hormone (Lh), Over The Counter NGE

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