Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031823359

FEI Number

3031823359

Entity Name

CorDx, Inc.

City/State/Country

Alpharetta, GA, US

Establishment Address

5900 Windward Pkwy, Alpharetta, GA 30005, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CorDx (Owner Number: 10050914)

Owner / Operator Contact Address

5900 Windward Pkwy, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACCU NEWS One Step hCG Pregnancy Test Strip ACCU NEWS One Step hCG Pregnancy Test Cassette ACCU NEWS Ovulation Test + Pregnancy Test Combo ACCU NEWS Pregnancy Test Strip ACCU NEWS Pregnancy Test Cassette ACCU NEWS Pregnancy Test Midstream ACCU NEWS One Step hCG Pregnancy Test Midstream CorDx Tyfast Pregnancy Test Strip CorDx Tyfast Pregnancy Test Midstream CorDx Tyfast Pregnancy Test Cassette CorDx Tyfast Cotinine (COT) Rapid Test Strip CorDx Tyfast Cotinine (COT) Rapid Test Cassette CorDx Tyfast FSH Rapid Test Midstream CorDx Tyfast FSH Rapid Test Strip CorDx Tyfast FSH Rapid Test Cassette ACCU NEWS Ovulation Test + Pregnancy Test Combo CorDx Tyfast Ovulation Test Midstream CorDx Tyfast Ovulation Test Strip CorDx Tyfast Ovulation Test Strip + Pregnancy Test Strip CorDx Tyfast Ovulation Test Cassette CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2016-01-15
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2026-02-24
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2026-02-24
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2016-01-15
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-03-27

Official Correspondent

Amber Wen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CorDx

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

Similar Registrations

Registration Number	Establishment Name	Location
1051594	CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.)	MORRISTOWN, TN, US
3007583565	SPD DEVELOPMENT COMPANY LIMITED	Bedford, GB
3012725363	EASY HEALTHCARE CORPORATION	Darien, IL, US
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
3003741676	ANDON HEALTH CO., LTD	TIANJIN, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031823359. Last updated year: 2026. Please use registration number 3031823359 when referencing this establishment in official correspondence.