Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010864358

FEI Number

3010864358

Entity Name

NOWDIAGNOSTICS, INC.

City/State/Country

Springdale, AR, US

Establishment Address

1200 STEWART PL, Springdale, AR 72764, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Now Diagnostics, Inc. (Owner Number: 10048184)

Owner / Operator Contact Address

1200 Stewart Place, Springdale, AR 72764, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ADEXUSDx First to Know Pregnancy Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2014-12-15
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2019-12-27

Official Correspondent

Amairani Lester

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Now Diagnostics, Inc.

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
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
K904016	Bhc Biotech , Ltd.	MAXI TEST	1990-10-15
K870259	Leeco Diagnostics, Inc.	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	1987-03-10
K820822	Hybritech, Inc.	TANDEM HCG KIT	1982-04-29
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

Similar Registrations

Registration Number	Establishment Name	Location
2060833	ALFA SCIENTIFIC DESIGNS, INC.	POWAY, CA, US
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
2027969	Alere San Diego, Inc.	San Diego, CA, US
1222302	American Laboratory Products Company	Salem, NH, US
2032364	VICTORCH MEDITEK, INC.	San Diego, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010864358. Last updated year: 2026. Please use registration number 3010864358 when referencing this establishment in official correspondence.