Kit, Test, Pregnancy, Hcg, Over The Counter

LCX 2025-07-15

Shinetell PlusTM Digital Early Pregnancy Test

Applicant Hangzhou AllTest Biotech Co., Ltd.

K number K251053

LCX 2025-02-13

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

Applicant Assure Tech., LLC

K number K250117

LCX 2025-01-31

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

Applicant Nanjing Synthgene Medical Technology Co., Ltd.

K number K242135

LCX 2025-01-15

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

Applicant Assure Tech., LLC

K number K243573

LCX 2024-12-20

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip

Applicant Andon Health Co, Ltd.

K number K241394

LCX 2024-10-11

HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

Applicant Anhui Deepblue Medical Technology Co., Ltd.

K number K240242

LCX 2024-08-13

Shinetell Digital Pregnancy Test

Applicant Hangzhou AllTest Biotech Co., Ltd.

K number K241978

LCX 2024-06-21

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K number K240643

LCX 2024-05-31

Distinct® Digital Pregnancy Test

Applicant ACON Laboratories, Inc.

K number K232715

LCX 2024-04-12

HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx

Applicant Hangzhou Aichek Medical Technology Co., Ltd.

K number K233624

LCX 2024-04-05

ACESO Early Pregnancy Test

Applicant Aceso Laboratories, Inc.

K number K234152

LCX 2024-02-05

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream

Applicant Assure Tech. (Hangzhou) Co, Ltd.

K number K233174

LCX 2024-01-31

Clearblue® Early Detection Pregnancy Test

K number K240025

LCX 2024-01-26

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

Applicant Nantong Egens Biotechnology Co., Ltd.

K number K232864

LCX 2023-10-13

Macro & Micro-Test HCG Pregnancy Test Midstream

Applicant Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

K number K230741

LCX 2023-02-28

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K number K230038

LCX 2022-11-30

MissLan™ Digital Pregnancy Rapid Test

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K number K222305

LCX 2022-09-21

Clearblue ® Early Pregnancy Test

K number K213379

LCX 2022-06-30

hCG One Step Pregnancy Test

Applicant Healstone Biotech, Inc.

K number K212418

LCX 2022-04-05

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream

Applicant Co-Innovation Biotech Co., Ltd.

K number K213808

LCX 2022-03-10

One Step Pregnancy Test

K number K210341

LCX 2022-02-18

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream

Applicant Hangzhou Sejoy Electronics & Instruments Co., Ltd.

K number K212447

LCX 2021-08-13

Clearblue® Early Digital Pregnancy Test

K number K200913

LCX 2021-08-04

Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)

Applicant Atlas Link Technology Co., Ltd.

K number K203246

LCX 2020-08-20

Distinct® Early Detection Pregnancy Test

Applicant ACON Laboratories, Inc.

K number K193318

LCX 2020-08-13

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K number K200133

LCX 2019-12-11

CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream

Applicant Hangzhou Clongene Biotech Co., Ltd.

K number K193132

LCX 2019-11-22

INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream

Applicant Innovita (Tangshan) Biological Technology Co., Ltd.

K number K192843

LCX 2019-09-05

HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream

Applicant Qingdao Hightop Biotech Co., Ltd.

K number K192123

LCX 2019-05-15

VeriClear Digital Early Result Pregnancy Test

Applicant True Diagnostics, Inc.

K number K182328

LCX 2019-04-15

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream

Applicant Wholepower Biotech Co., Ltd.

K number K190705

LCX 2019-02-22

DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette

Applicant Runbio Biotech Co.,Ltd

K number K181551

LCX 2019-01-10

Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream

Applicant Weihai Kangzhou Biotechnology Engineering Co., Ltd.

K number K183097

LCX 2018-05-18

Acro HCG Pregnancy Rapid Test

Applicant Acro Biotech, Inc.

K number K180771

LCX 2018-03-28

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette

Applicant Runbio Biotech Co.,Ltd

K number K172627

LCX 2018-03-12

Preview Digital Pregnancy Test

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K number K173229

LCX 2018-02-02

ACRO HCG Pregnancy Rapid Test

Applicant Acro Biotech, Inc.

K number K172512

LCX 2017-11-20

LIA Pregnancy Test

Applicant Lia Diagnostics

K number K171136

LCX 2016-04-07

Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test

Applicant Sugentech, Inc.

K number K142754

LCX 2013-11-12

ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM

Applicant Co-Innovation Biotech Co., Ltd.

K number K132085

LCX 2013-11-07

UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP

Applicant Ucp Biosciences, Inc.

K number K131236

LCX 2013-09-10

FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST

K number K123567

LCX 2013-08-26

FIRST RESPONSE EARLY RESULT PREGNANCY TEST

K number K123436

LCX 2013-07-26

CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST

Applicant Chemtron Biotech, Inc.

K number K131931

LCX 2013-04-10

HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)

Applicant Healgen Scientific,, LLC

K number K123703

LCX 2013-03-14

FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER

Applicant Polymed Therapeutics, Inc.

K number K122907

LCX 2013-02-05

EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

Applicant Nantong Biotechnology Co., Ltd.

K number K123050

LCX 2012-09-24

QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST

Applicant Tianjin New Bay Bioresearch Co., Ltd.

K number K112449

LCX 2011-10-04

FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

Applicant Taidoc Technology Corporation

K number K103487

LCX 2011-08-03

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001

Applicant Atlas Medical

K number K102760

LCX 2011-07-28

PREGNANCY ONE STEP RAPID TEST

Applicant Lehnus & Associates Consulting

K number K103574

LCX 2011-06-20

IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)

Applicant Ind Diagnostics, Inc.

K number K110889

LCX 2011-05-12

CLEARBLUE EASY PREGNANCY TEST

Applicant SPD Development Company Limited

K number K110433

LCX 2009-06-16

RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST

Applicant Turklab Medical Devices, Inc.

K number K081150

LCX 2009-06-08

FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)

K number K083716

LCX 2007-12-18

ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C

Applicant Blue Cross Bio-Medical Co., Ltd.

K number K071930

LCX 2007-07-23

ONE STEP HCG PREGNANCY TEST

Applicant Ai DE Diagnostic Co., Ltd.

K number K062703

LCX 2007-05-07

KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST

Applicant Koreamedico Co. , Ltd.

K number K062096

LCX 2007-05-04

FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST

K number K070054

LCX 2006-07-18

DAVID PREGNANCY TEST (MIDSTREAM)

Applicant Runbio Biotech Co.,Ltd

K number K053236

LCX 2006-07-03

E.P.T. CERTAINTY 1-STEP PREGNANCY TEST

Applicant Unipath , Ltd.

K number K061769

LCX 2006-06-19

MULTI-USE ELECTRONIC PREGNANCY TEST

Applicant Mizuho USA, Inc.

K number K060825

LCX 2006-05-25

CLEARBLUE EASY DIGITAL PREGNANCY TEST

Applicant Unipath , Ltd.

K number K060128

LCX 2006-05-25

PURE-AID PREGNANCY TEST

Applicant Bio Focus Co., Lt.

K number K053452

LCX 2006-03-01

MYSET PREGNANCY TEST

Applicant Ani Biotech OY

K number K053138

LCX 2006-02-17

ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)

Applicant Artron Laboratories, Inc.

K number K060019

LCX 2005-11-23

BE-CERTAIN PREGNANCY TEST

Applicant Natureplex, LLC

K number K051963

LCX 2005-05-23

ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2

Applicant Bioscreen Medical, Inc.

K number K050305

LCX 2005-05-20

ACON +/- MIDSTREAM PREGNANCY TEST

Applicant ACON Laboratories, Inc.

K number K050546

LCX 2005-05-12

E.P.T. CERTAINTY PREGNANCY TEST

Applicant Unipath , Ltd.

K number K050930

LCX 2005-04-25

PROOF POSITIVE ELECTRONIC PREGNANCY TEST

Applicant Mizuho USA, Inc.

K number K043231

LCX 2005-04-08

ONE STEP HCG URINE PREGNANCY TEST

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K number K043443

LCX 2004-10-19

FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST

Applicant Armkel, LLC

K number K040866

LCX 2004-09-10

FACT PLUS ONE-STEP PREGNANCY TEST KIT

Applicant Unipath , Ltd.

K number K042280

LCX 2004-09-09

ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST

Applicant ACON Laboratories, Inc.

K number K042151

LCX 2004-08-09

AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)

Applicant Azog, Inc.

K number K041748

LCX 2004-06-08

CLEARBLUE EASY EASY READ PREGNANCY TEST

Applicant Unipath , Ltd.

K number K041404

LCX 2004-05-20

ONE-STEP PREGNANCY TEST

Applicant W.H.P.M., Inc.

K number K041273

LCX 2004-03-08

CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST

Applicant Unipath , Ltd.

K number K040341

LCX 2004-03-08

MODIFICATION TO E.P.T. PREGNANCY TEST

Applicant Unipath , Ltd.

K number K040329

LCX 2004-01-16

E.P.T. PREGNANCY TEST

Applicant Unipath , Ltd.

K number K033658

LCX 2003-11-21

ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP

Applicant ACON Laboratories, Inc.

K number K033041

LCX 2003-11-21

UNIMARK HOME PREGNANCY TEST DEVICE

Applicant Biotech Atlantic, Inc.

K number K032992

LCX 2003-11-12

GOOD MORNING TEST

Applicant Standard Diagnostics, Inc.

K number K031798

LCX 2003-10-20

EPT CERTAINTY PREGNANCY TEST

Applicant Unipath , Ltd.

K number K032939

LCX 2003-10-14

ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)

Applicant ACON Laboratories, Inc.

K number K032661

LCX 2003-09-22

ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST

Applicant ACON Laboratories, Inc.

K number K032510

LCX 2003-09-05

CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

Applicant Access Bio Incorporate

K number K032159

LCX 2003-06-17

ONE-STEP PREGNANCY TEST

Applicant Amerisource Pharmacal, Inc.

K number K031271

LCX 2003-05-02

CLEARBLUE EASY DIGITAL PREGNANCY TEST

Applicant Unipath , Ltd.

K number K030659

LCX 2003-04-17

ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST

Applicant Cenogenics Corp.

K number K030533

LCX 2003-04-09

MID STREAM PREGNANCY TEST

Applicant Advanced Diagnostics, Inc.

K number K023037

LCX 2003-02-25

FIRST RESPONSE PREGNANCY TEST

Applicant Armkel, LLC

K number K030258

LCX 2003-01-03

CASSETTE/URINE HCG

Applicant Ind Diagnostic, Inc.

K number K023638

LCX 2002-12-16

PREG-Q EARLY PREGNANCY TEST

Applicant Yd Diagnostics

K number K023027

LCX 2002-11-27

CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

Applicant Unipath , Ltd.

K number K023699

LCX 2002-11-18

AMEDITECH IMMUTEST HCG PREGANCY TEST

Applicant Ameditech, Inc.

K number K023126

LCX 2001-12-18

INVERNESS MEDICAL EARLY PREGNANCY TEST

Applicant Cambridge Diagnostics Ireland, Ltd.

K number K013907

LCX 2001-11-09

CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

Applicant Unipath , Ltd.

K number K013372