Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005128563

FEI Number

3005128563

Entity Name

Abbott Diagnostics (Shanghai) Co., Ltd.

City/State/Country

Shanghai, CN

Establishment Address

151 LIBING ROAD, Pilot Free Trade Zone, Shanghai 201203, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Clearblue Pregnancy Planning Kit Clearblue Digital and Visual Pregnancy Kit Clearblue Visual Preg Test Kroger +/- Preg Test Best Choice +/- Preg Test Western Family +/- Preg Test Shur Fine +/- Preg Test Rite Aid Early Pregnancy Bilingual Test Walgreens Early Pregnancy Bilingual Test Walmart Equate Visual Early Preg Test Hy-Vee Visual Early Preg Test Topcare Visual Early Preg Test HEB Bi-Ling Early Preg Test Best Choice Early Preg Test Walmart Equate +/- Preg Test Western Family Visual Early Preg Test Health Mart +/- Preg Test Loblaws +/- Preg Test Sunmark +/- Preg Test Meijer +/- Preg Test Target Visual Early Preg Test London Drug +/- Preg Test Pharmasave +/- Preg Test Shopko Visual Early Preg Test Rite Aid +/- Preg Test SDM +/- Preg Test CVS Visual Early Preg Test Loblaws Visual Early Preg Test Target +/- Preg Test Shopko +/- Preg Test Exchange Select +/- Preg Test Fact Plus +/- Preg Test Walgreens Visual Early Preg Test Meijer Visual Early Preg test Discount Drug +/- Preg Test Generic +/- Preg Test Equaline Visual Early Preg Test Good Sense Visual Early Preg Test Good Sense +/- Preg Test Clearblue Fertility Monitor Sticks Clearblue Fertility Monitor Walmart Equate Early Ovulation Clearblue Connected Ovulation Test System Clearblue +/- Ovulation and Digital Pregnancy Clearblue +/- Ovulation Test Clearblue Preg Planning Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2006-01-31
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2011-12-01
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-11-13
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2008-03-10
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-04-28
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2023-06-13
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2009-12-15
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2007-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

Yingying Wang Business: Alere Inc. Email: yingying.wang@abbott.com Phone: (224) 5320210

Related Public Records

Same Entity

ABBOTT LABORATORIES

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

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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2060833	ALFA SCIENTIFIC DESIGNS, INC.	POWAY, CA, US
3013160357	RR Donnelley Global Turnkey Solutions	Juarez Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005128563. Last updated year: 2026. Please use registration number 3005128563 when referencing this establishment in official correspondence.