Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013167221

FEI Number

3013167221

Entity Name

KINGSWAY PHARMACEUTICALS DBA NFI, LLC

City/State/Country

Bristol, TN, US

Establishment Address

636 Shelby Street, Suite 300, Bristol, TN 37620, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

Kingsway Pharmaceuticals dba NFI, LLC (Owner Number: 10053911)

Owner / Operator Contact Address

636 Shelby Street, Suite 300, Bristol, TN 37620, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222305

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2025-09-26
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-12-09
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-12-09
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2025-12-09
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-12-09
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2026-03-03
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2026-03-03
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2025-12-09
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-12-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kingsway Pharmaceuticals dba NFI, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07
K043443	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE PREGNANCY TEST	2005-04-08
K173229	Guangzhou Wondfo Biotech Co., Ltd.	Preview Digital Pregnancy Test	2018-03-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013167221. Last updated year: 2026. Please use registration number 3013167221 when referencing this establishment in official correspondence.