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Helicobacter Pylori

FDA product code LYR · 89 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.3110
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1988-10-06 – 2023-12-15

LYR 2023-12-15

Hp Detect™ Stool Antigen ELISA

Applicant Biomerica, Inc.

K number K232892

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LYR 2023-07-03

Premier HpSA Flex (619096)

Applicant Meridian Bioscience, Inc.

K number K230901

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LYR 2020-03-13

Curian HpSA, Curian Analyzer

Applicant Meridian Bioscience, Inc.

K number K192817

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LYR 2019-03-14

Vstrip H. pylori Antigen Rapid Test

Applicant Panion & BF Biotech, Inc.

K number K183573

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LYR 2018-11-05

PREMIER Platinum HpSA PLUS

Applicant Meridian Bioscience, Inc.

K number K182559

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LYR 2018-08-31

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

Applicant DiaSorin, Inc.

K number K181464

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LYR 2018-08-21

H. PYLORI CHEK™

Applicant Techlab, Inc.

K number K181400

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LYR 2018-08-21

H. PYLORI QUIK CHEK

Applicant Techlab, Inc.

K number K181379

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LYR 2016-07-22

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set

Applicant DiaSorin, Inc.

K number K161139

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LYR 2016-03-14

ImmunoCard STAT! HpSA

Applicant Meridian Bioscience, Inc.

K number K153661

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LYR 2012-03-02

HELICOBACTER PYLORI ELISA IGG TEST KIT

Applicant Gold Standard Diagnostics

K number K110745

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LYR 2012-02-01

GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT

Applicant Gold Standard Diagnostics

K number K110899

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LYR 2006-11-16

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT

Applicant Otsuka Pharmaceutical Co., Ltd.

K number K052716

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LYR 2006-05-01

PYLO-PLUS

Applicant Arj Medical, Inc.

K number K052708

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LYR 2006-03-10

PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480

Applicant Meridian Bioscience, Inc.

K number K053335

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LYR 2004-12-13

HELICOBACTER PYLORI IGG ELISA

Applicant Biohit Plc

K number K041238

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LYR 2003-12-05

IMMUNOCARDSTAT HPSA

Applicant Meridian Bioscience, Inc.

K number K032222

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LYR 2003-11-26

PYLORI IGG

Applicant Trinity Biotech USA

K number K033067

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LYR 2003-06-10

INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST

Applicant Alfa Scientific Designs, Inc.

K number K024360

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LYR 2003-04-02

ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K024350

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LYR 2003-03-27

QUANTA LITE H.PYLORI IGA ELISA

Applicant Inova Diagnostics, Inc.

K number K024334

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LYR 2002-10-25

NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY

Applicant Nichols Institute Diagnostics

K number K022356

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LYR 2002-02-08

PYLORITEK VP TEST KIT 5140VP

Applicant Serim Research Corp.

K number K014038

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LYR 2001-12-10

OXOID PYLORI TEST KIT, MODEL DR0130M

Applicant Oxoid , Ltd.

K number K012588

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LYR 2001-09-25

HP-ONE

Applicant Gi Supply

K number K012411

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LYR 2001-03-30

ELISA TEST, SEROLOGY

Applicant Micro Detect, Inc.

K number K003794

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LYR 2000-11-13

MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714

Applicant Medmira Laboratories, Inc.

K number K002023

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LYR 2000-11-13

PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI

Applicant Enteric Products, Inc.

K number K001177

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LYR 2000-10-04

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192

Applicant bioMerieux, Inc.

K number K001460

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LYR 2000-09-29

MODIFICATION TO: PRONTO DRY

Applicant Medical Instruments Corporation, AG

K number K002451

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LYR 2000-06-01

IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG

Applicant Diagnostic Products Corp.

K number K000463

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LYR 1999-12-21

UNI-GOLD H. PYLORI

Applicant Trinity Biotech, Plc

K number K991697

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LYR 1999-09-03

IS H. PYLORI IGG ELISA TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K990462

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LYR 1999-08-12

HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI

Applicant Zeus Scientific, Inc.

K number K991820

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LYR 1999-08-04

QUICKVUE ONE-STEP H. PYLORI II TEST

Applicant Quidel Corp.

K number K991747

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LYR 1999-06-22

PRONTO DRY

Applicant Medical Instruments Corporation Mic AG

K number K991248

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LYR 1999-02-18

THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S

Applicant Enteric Products, Inc.

K number K984544

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LYR 1998-12-17

MODIFICATION TO: PREMIER PLATINUM HPSA

Applicant Meridian Diagnostics, Inc.

K number K983255

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LYR 1998-11-18

ABBOTT TESTPACK PLUS H. PYLORI

Applicant Abbott Laboratories

K number K982362

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LYR 1998-11-04

QUANTA LITE H. PYLORI IGG ELISA

Applicant Inova Diagnostics, Inc.

K number K982790

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LYR 1998-09-22

BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST

Applicant Princeton BioMeditech Corp.

K number K980798

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LYR 1998-08-05

STAT-SIMPLE PYLORI

Applicant Saliva Diagnostic Systems, Inc.

K number K980782

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LYR 1998-07-30

PYLORIPROBE

Applicant Amdl, Inc.

K number K981396

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LYR 1998-07-30

HELICOBACTER PYLORI IGG ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K980821

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LYR 1998-05-12

PREMIER PLATINUM HPSA

Applicant Meridian Diagnostics, Inc.

K number K980076

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LYR 1998-03-17

SHIELD HELICO-G2 ELISA KIT

Applicant Shield Diagnostics, Ltd.

K number K972981

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LYR 1998-03-10

PYLORI DETECT IGG

Applicant Micro Detect, Inc.

K number K973508

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LYR 1998-03-03

ACCUSTAT H. PYLORI ONE STEP TEST

Applicant Boehringer Mannheim Corp.

K number K973523

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LYR 1997-07-08

QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS

Applicant Consolidated Technologies, Inc.

K number K972146

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LYR 1997-06-27

PYLORISET EIA-G (68926)

Applicant Orion Diagnostica, Div. Orion Corp.

K number K971537

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LYR 1997-03-03

KENLOR H. PYLORI CONTROL SERUM

Applicant Kenlor Industries, Inc.

K number K964014

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LYR 1997-02-20

ACCUMETER H. PYLORI TEST

Applicant Chemtrak, Inc.

K number K965099

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LYR 1997-01-27

H.PYLORI CONTROLS

Applicant Pyramid Biological Corp.

K number K964675

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LYR 1997-01-21

IMMUNOCARD H. PYLORI

Applicant Meridian Diagnostics, Inc.

K number K961508

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LYR 1996-09-17

MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT

Applicant Meretek Diagnostics, Inc.

K number K952220

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LYR 1996-08-30

VARELISA HELICOBACTER PYLORI ANTIBODIES

Applicant Elias U.S.A., Inc.

K number K953873

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LYR 1996-07-30

PYLORI IGG ELISA TEST SYSTEM

Applicant Armkel, LLC

K number K961221

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LYR 1996-06-27

ACCUMETER H. PYLORI TEST

Applicant Chemtrak, Inc.

K number K960478

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LYR 1996-06-07

FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)

Applicant Smithkline Diagnostics, Inc.

K number K960183

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LYR 1996-05-21

HELISAL RAPID BLOOD TEST

Applicant Cortecs, Ltd.

K number K953686

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LYR 1996-02-09

HM-CAP EIA TEST (MODIFICATION)

Applicant Schiff & Co.

K number K955085

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LYR 1996-02-06

QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST

Applicant Quidel Corp.

K number K952517

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LYR 1996-01-30

HM-CAP CONTROL PANEL

Applicant E-Z-Em, Inc.

K number K954926

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LYR 1995-12-18

SERIM PYLORITEK TEST KIT

Applicant Serim Research Corp.

K number K953632

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LYR 1995-07-18

HM-CAP EIA KIT

Applicant Schiff & Co.

K number K944159

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LYR 1995-05-11

PS II

Applicant Washington Biotechnology

K number K943513

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LYR 1995-04-20

HP-FAST

Applicant Gi Supply

K number K944903

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LYR 1995-04-05

PYLORISET DRY

Applicant Orion Diagnostica, Div. Orion Corp.

K number K942974

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LYR 1995-03-03

PREMIER(TM) H. PYLORY

Applicant Meridian Diagnostics, Inc.

K number K945558

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LYR 1994-12-08

IMMUNOCARD H. PYLORI

Applicant Meridian Diagnostics, Inc.

K number K941560

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LYR 1994-05-18

FLEXSURE HP

Applicant Smithkline Diagnostics, Inc.

K number K934863

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LYR 1993-08-10

UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG

Applicant United Biotech, Inc.

K number K924689

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LYR 1993-03-23

PYLORISCREEN

Applicant New Horizons Diagnostics Co.

K number K925190

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LYR 1992-09-11

PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED

Applicant Hycor Biomedical, Inc.

K number K923445

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LYR 1992-07-14

AMRAD HEL-PTEST

Applicant Amrad

K number K920827

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LYR 1992-03-04

GAP IGG H.PYLORI MODIFIED

Applicant Biomerica, Inc.

K number K915185

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LYR 1992-02-21

QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)

Applicant Quidel Corp.

K number K915851

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LYR 1991-10-21

PYLORISET

Applicant Orion Diagnostica, Inc.

K number K904655

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LYR 1991-10-11

HYCOR PYLORAGEN HELICOBACTER PYLORI TEST

Applicant Hycor Biomedical, Inc.

K number K912255

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LYR 1991-10-04

PYLORITRAK

Applicant Bainbridge Laboratories, Inc.

K number K912215

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LYR 1991-09-16

QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST

Applicant Quidel Corp.

K number K912442

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LYR 1991-08-22

GAP-IGG

Applicant Biomerica, Inc.

K number K900343

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LYR 1991-06-10

EIA FOR DETECTION OF ANTIBODIES H. PYLORI

Applicant E-Z-Em, Inc.

K number K905409

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LYR 1991-05-07

PYLORI-G FIAX TEST KIT

Applicant Whittaker Bioproducts, Inc.

K number K905468

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LYR 1991-05-07

QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR

Applicant Quidel Corp.

K number K905049

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LYR 1991-05-07

PYLORI STAT TEST KIT

Applicant Whittaker Bioproducts, Inc.

K number K904738

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LYR 1991-04-17

QUIDEL HELICOBACTER PYLORI TEST

Applicant Quidel Corp.

K number K903099

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LYR 1989-05-04

SELECTIVE RAPID UREA

Applicant Remel Co.

K number K883641

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LYR 1988-10-06

CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST

Applicant Auspharm Intl. , Ltd.

K number K882199

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