System, Test, Human Chorionic Gonadotropin

FDA product code DHA · 71 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1155
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1986-08-19 – 2024-05-08

DHA 2024-05-08

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

Applicant Ortho Clinical Diagnostics

K number K233581

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DHA 2023-12-11

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

Applicant Shenzhen Yhlo Biotech Co., Ltd.

K number K223690

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DHA 2023-06-05

Alinity i Total ß-hCG Reagent Kit, GLP systems Track

Applicant Abbott Laboratories

K number K230937

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DHA 2023-05-19

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

Applicant Abbott Laboratories

K number K230790

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DHA 2022-12-27

Access Total ßhCG (5th IS)

Applicant Beckman Coulter, Inc.

K number K221990

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DHA 2021-12-13

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

Applicant Diazyme Laboratories, Inc.

K number K212221

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DHA 2021-08-18

Elecsys HCG STAT

Applicant Roche Diagnostics

K number K203227

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DHA 2021-07-13

ADVIA Centaur® Total hCG assay

Applicant Siemens Healthcare Diagnostics, Inc.

K number K200210

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DHA 2020-01-17

MAGLUMI 2000 HCG/ß-HCG

Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd.

K number K192547

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DHA 2019-10-30

Atellica IM Total hCG (ThCG)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K192790

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DHA 2017-10-23

Alinity i Total ß-hCG Reagent Kit, Alinity i System

Applicant Abbott Laboratories

K number K170317

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DHA 2017-08-18

Diazyme DZ-Lite Total beta-hCG Test System

Applicant Diazyme Laboratories

K number K163418

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DHA 2013-10-01

ACCESS TOTAL BHCG (5TH IS)

Applicant Beckman Coulter, Inc.

K number K130020

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DHA 2013-09-06

LIAISON XL HCG

Applicant DiaSorin, Inc.

K number K131037

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DHA 2009-04-21

ONE STEP HCG URINE/SERUM TEST

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K number K072500

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DHA 2008-09-03

OLYMPUS TOTAL BHCG TEST SYSTEN

Applicant Olympus Life Science Research Europa GmbH (Europa)

K number K080094

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DHA 2007-04-09

VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS

Applicant Ortho-Clinical Diagnostics

K number K063720

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DHA 2007-02-23

DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632

Applicant Dade Behring, Inc.

K number K063754

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DHA 2006-04-06

STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK

Applicant Dade Behring, Inc.

K number K060548

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DHA 2004-12-17

NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY

Applicant Nichols Institute Diagnostics

K number K042676

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DHA 2003-12-12

IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

Applicant Diagnostic Products Corp.

K number K033234

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DHA 2003-06-13

CARESTART HCG ONE-STEP PREGNANCY TEST

Applicant Access Bio Incorporate

K number K031052

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DHA 2002-11-01

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)

Applicant Azog, Inc.

K number K022681

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DHA 2002-11-01

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)

Applicant Azog, Inc.

K number K022680

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DHA 2002-01-22

AIMSTEP PREGNANCY

Applicant Germaine Laboratories, Inc.

K number K013857

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DHA 2001-12-27

VICTORCH MEDITEK'S HCG TEST CARD

Applicant Victorch Meditek, Inc.

K number K013678

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DHA 2001-01-25

STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD

Applicant Dade Behring, Inc.

K number K003696

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DHA 2000-12-14

ELECSYS HCG AND BETA TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K003178

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DHA 2000-08-22

ELECSYS HCG TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K002148

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DHA 2000-06-16

ABSOLUTE HCG PREGNANCY TEST

Applicant Mizuho USA, Inc.

K number K000844

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DHA 2000-01-28

IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5

Applicant Diagnostic Products Corp.

K number K994085

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DHA 1999-09-17

DRX QT. HCG

Applicant Metrika, Inc.

K number K991532

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DHA 1999-05-28

INSURE PREGNANCY TEST

Applicant Inbios Intl., Inc.

K number K991515

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DHA 1999-02-26

IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6

Applicant Diagnostic Products Corp.

K number K990222

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DHA 1998-12-01

ABBOTT ARCHEITECT TOTAL B-HCG

Applicant Abbott Laboratories

K number K983424

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DHA 1998-01-02

AIMSTICK PBD COMBO PREGNANCY

Applicant Germaine Laboratories, Inc.

K number K974512

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DHA 1998-01-02

AIMSTICK PBD PREGNANCY

Applicant Germaine Laboratories, Inc.

K number K974368

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DHA 1997-12-24

BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST

Applicant Princeton BioMeditech Corp.

K number K974425

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DHA 1997-12-19

MIDSTREAM HOME REGNANCY TEST

Applicant Germaine Laboratories, Inc.

K number K973825

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DHA 1997-04-14

VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K970894

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DHA 1997-03-10

HUMAN CHORIONIC GONADOTROPIN METHOD

Applicant Dade Chemistry Systems, Inc.

K number K970387

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DHA 1996-08-21

BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS

Applicant Biocircuits Corp.

K number K961792

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DHA 1996-06-12

ELECSYS HCG ASSAY

Applicant Boehringer Mannheim Corp.

K number K961487

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DHA 1996-06-03

HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD

Applicant Bayer Corp.

K number K961351

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DHA 1996-05-02

ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT

Applicant Excel Scientific, Inc.

K number K955707

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DHA 1995-07-17

AMERLITE HCG-60 ASSAY

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K952283

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DHA 1995-03-20

AURAFLEX HCG

Applicant Organon Teknika Corp.

K number K945331

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DHA 1995-03-01

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST

Applicant Princeton BioMeditech Corp.

K number K950307

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DHA 1994-08-18

SEALITE SCIENCES INC.

Applicant Sealite Sciences, Inc.

K number K941983

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DHA 1994-06-02

UNISTEP HCG PREGNANCY TEST STRIP

Applicant Biotech Atlantic, Inc.

K number K941090

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DHA 1993-06-29

SAS(TM) SERUM/URINE HCG

Applicant Sa Scientific, Inc.

K number K932409

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DHA 1992-10-19

STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant Baxter Diagnostics, Inc.

K number K922073

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DHA 1991-08-16

STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant Baxter Healthcare Corp

K number K913236

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DHA 1991-06-20

IMMULITE(TM) HCG

Applicant Cirrus Diagnostics, Inc.

K number K911796

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DHA 1989-08-21

SINGLE AND DUAL BAND DIPSTICK HCG TEST

Applicant Ampcor, Inc.

K number K893873

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DHA 1989-08-15

ABSOLUTE(TM)-HCG URINE PREGNANCY TEST

Applicant Totem Diagnostics, Inc.

K number K893953

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DHA 1989-08-03

STATUS HCG FLUOROMETRIC ENZYME

Applicant Baxter Healthcare Corp

K number K893577

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DHA 1989-06-19

BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST

Applicant Princeton Biomedix

K number K892654

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DHA 1989-06-16

VIS-DISK HCG (EIA) JPL-041M

Applicant Leeco Diagnostics, Inc.

K number K891096

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DHA 1989-06-16

VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M

Applicant Leeco Diagnostics, Inc.

K number K891095

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DHA 1988-12-09

SERUM HCG MICROASSAY

Applicant Diamedix Corp.

K number K884430

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DHA 1988-12-05

IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K883148

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DHA 1988-12-02

RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO

Applicant Abbott Laboratories

K number K884207

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DHA 1988-11-10

HYGEIA URINE PREGNANCY TEST

Applicant Hygeia Sciences

K number K882192

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DHA 1988-10-31

ONE-STEP HCG

Applicant Wampole Laboratories

K number K882896

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DHA 1988-10-12

MODIFIED BETA QUIK STAT EIA KIT

Applicant Pacific Biotech, Inc.

K number K882895

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DHA 1988-09-30

RAPIDTEST-HCG (TM)

Applicant Synbiotics Corp.

K number K883235

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DHA 1988-04-05

MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY

Applicant Ventrex Laboratories, Inc.

K number K880678

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DHA 1988-02-02

BETA-HCG ASSAY

Applicant Schiff & Co.

K number K873986

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DHA 1987-10-28

HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013

Applicant Medix Biotech, Inc.

K number K873872

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DHA 1986-08-19

ENZYMUN-TEST HCG

Applicant Boehringer Mannheim Corp.

K number K862108

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