| Hp Detect™ Stool Antigen ELISA (K232892) | Biomerica, Inc. | 2023-12-15 |
| Premier HpSA Flex (619096) (K230901) | Meridian Bioscience, Inc. | 2023-07-03 |
| Curian HpSA, Curian Analyzer (K192817) | Meridian Bioscience, Inc. | 2020-03-13 |
| Vstrip H. pylori Antigen Rapid Test (K183573) | Panion & BF Biotech, Inc. | 2019-03-14 |
| PREMIER Platinum HpSA PLUS (K182559) | Meridian Bioscience, Inc. | 2018-11-05 |
| LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (K181464) | DiaSorin, Inc. | 2018-08-31 |
| H. PYLORI QUIK CHEK (K181379) | Techlab, Inc. | 2018-08-21 |
| H. PYLORI CHEK™ (K181400) | Techlab, Inc. | 2018-08-21 |
| LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (K161139) | DiaSorin, Inc. | 2016-07-22 |
| ImmunoCard STAT! HpSA (K153661) | Meridian Bioscience, Inc. | 2016-03-14 |
| Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only (K151935) | Alere San Diego, Incorporated | 2015-08-12 |
| VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (K141133) | BIOMERIEUX | 2015-07-09 |
| HELICOBACTER PYLORI ELISA IGG TEST KIT (K110745) | Gold Standard Diagnostics | 2012-03-02 |
| GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT (K110899) | Gold Standard Diagnostics | 2012-02-01 |
| RAPIRUN H. PYLORI ANTIBODY DETECTION KIT (K052716) | Otsuka Pharmaceutical Co., Ltd. | 2006-11-16 |
| PYLO-PLUS (K052708) | Arj Medical, Inc. | 2006-05-01 |
| PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 (K053335) | Meridian Bioscience, Inc. | 2006-03-10 |
| HELICOBACTER PYLORI IGG ELISA (K041238) | Biohit Plc | 2004-12-13 |
| IMMUNOCARDSTAT HPSA (K032222) | Meridian Bioscience, Inc. | 2003-12-05 |
| PYLORI IGG (K033067) | Trinity Biotech USA | 2003-11-26 |
| INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST (K024360) | Alfa Scientific Designs, Inc. | 2003-06-10 |
| ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE (K024350) | ACON Laboratories, Inc. | 2003-04-02 |
| QUANTA LITE H.PYLORI IGA ELISA (K024334) | Inova Diagnostics, Inc. | 2003-03-27 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY (K022356) | Nichols Institute Diagnostics | 2002-10-25 |
| PYLORITEK VP TEST KIT 5140VP (K014038) | Serim Research Corp. | 2002-02-08 |
| OXOID PYLORI TEST KIT, MODEL DR0130M (K012588) | Oxoid , Ltd. | 2001-12-10 |
| HP-ONE (K012411) | Gi Supply | 2001-09-25 |
| ELISA TEST, SEROLOGY (K003794) | Micro Detect, Inc. | 2001-03-30 |
| MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 (K002023) | Medmira Laboratories, Inc. | 2000-11-13 |
| PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI (K001177) | Enteric Products, Inc. | 2000-11-13 |
| VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 (K001460) | bioMerieux, Inc. | 2000-10-04 |
| MODIFICATION TO: PRONTO DRY (K002451) | Medical Instruments Corporation, AG | 2000-09-29 |
| IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG (K000463) | Diagnostic Products Corp. | 2000-06-01 |
| UNI-GOLD H. PYLORI (K991697) | Trinity Biotech, Plc | 1999-12-21 |
| IS H. PYLORI IGG ELISA TEST SYSTEM (K990462) | Columbia Bioscience, Inc. | 1999-09-03 |
| HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI (K991820) | Zeus Scientific, Inc. | 1999-08-12 |
| QUICKVUE ONE-STEP H. PYLORI II TEST (K991747) | Quidel Corp. | 1999-08-04 |
| PRONTO DRY (K991248) | Medical Instruments Corporation Mic AG | 1999-06-22 |
| THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S (K984544) | Enteric Products, Inc. | 1999-02-18 |
| MODIFICATION TO: PREMIER PLATINUM HPSA (K983255) | Meridian Diagnostics, Inc. | 1998-12-17 |
| ABBOTT TESTPACK PLUS H. PYLORI (K982362) | Abbott Laboratories | 1998-11-18 |
| QUANTA LITE H. PYLORI IGG ELISA (K982790) | Inova Diagnostics, Inc. | 1998-11-04 |
| BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST (K980798) | Princeton BioMeditech Corp. | 1998-09-22 |
| STAT-SIMPLE PYLORI (K980782) | Saliva Diagnostic Systems, Inc. | 1998-08-05 |
| PYLORIPROBE (K981396) | Amdl, Inc. | 1998-07-30 |
| HELICOBACTER PYLORI IGG ELISA TEST SYSTEM (K980821) | Zeus Scientific, Inc. | 1998-07-30 |
| PREMIER PLATINUM HPSA (K980076) | Meridian Diagnostics, Inc. | 1998-05-12 |
| SHIELD HELICO-G2 ELISA KIT (K972981) | Shield Diagnostics, Ltd. | 1998-03-17 |
| PYLORI DETECT IGG (K973508) | Micro Detect, Inc. | 1998-03-10 |
| ACCUSTAT H. PYLORI ONE STEP TEST (K973523) | Boehringer Mannheim Corp. | 1998-03-03 |
| QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS (K972146) | Consolidated Technologies, Inc. | 1997-07-08 |
| PYLORISET EIA-G (68926) (K971537) | Orion Diagnostica, Div. Orion Corp. | 1997-06-27 |
| KENLOR H. PYLORI CONTROL SERUM (K964014) | Kenlor Industries, Inc. | 1997-03-03 |
| ACCUMETER H. PYLORI TEST (K965099) | Chemtrak, Inc. | 1997-02-20 |
| H.PYLORI CONTROLS (K964675) | Pyramid Biological Corp. | 1997-01-27 |
| IMMUNOCARD H. PYLORI (K961508) | Meridian Diagnostics, Inc. | 1997-01-21 |
| MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT (K952220) | Meretek Diagnostics, Inc. | 1996-09-17 |
| VARELISA HELICOBACTER PYLORI ANTIBODIES (K953873) | Elias U.S.A., Inc. | 1996-08-30 |
| PYLORI IGG ELISA TEST SYSTEM (K961221) | Armkel, LLC | 1996-07-30 |
| ACCUMETER H. PYLORI TEST (K960478) | Chemtrak, Inc. | 1996-06-27 |
| FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) (K960183) | Smithkline Diagnostics, Inc. | 1996-06-07 |
| HELISAL RAPID BLOOD TEST (K953686) | Cortecs, Ltd. | 1996-05-21 |
| HM-CAP EIA TEST (MODIFICATION) (K955085) | Schiff & Co. | 1996-02-09 |
| QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST (K952517) | Quidel Corp. | 1996-02-06 |
| HM-CAP CONTROL PANEL (K954926) | E-Z-Em, Inc. | 1996-01-30 |
| SERIM PYLORITEK TEST KIT (K953632) | Serim Research Corp. | 1995-12-18 |
| HM-CAP EIA KIT (K944159) | Schiff & Co. | 1995-07-18 |
| PS II (K943513) | Washington Biotechnology | 1995-05-11 |
| HP-FAST (K944903) | Gi Supply | 1995-04-20 |
| PYLORISET DRY (K942974) | Orion Diagnostica, Div. Orion Corp. | 1995-04-05 |
| PREMIER(TM) H. PYLORY (K945558) | Meridian Diagnostics, Inc. | 1995-03-03 |
| IMMUNOCARD H. PYLORI (K941560) | Meridian Diagnostics, Inc. | 1994-12-08 |
| FLEXSURE HP (K934863) | Smithkline Diagnostics, Inc. | 1994-05-18 |
| UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG (K924689) | United Biotech, Inc. | 1993-08-10 |
| PYLORISCREEN (K925190) | New Horizons Diagnostics Co. | 1993-03-23 |
| PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED (K923445) | Hycor Biomedical, Inc. | 1992-09-11 |
| AMRAD HEL-PTEST (K920827) | Amrad | 1992-07-14 |
| GAP IGG H.PYLORI MODIFIED (K915185) | Biomerica, Inc. | 1992-03-04 |
| QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG) (K915851) | Quidel Corp. | 1992-02-21 |
| PYLORISET (K904655) | Orion Diagnostica, Inc. | 1991-10-21 |
| HYCOR PYLORAGEN HELICOBACTER PYLORI TEST (K912255) | Hycor Biomedical, Inc. | 1991-10-11 |
| PYLORITRAK (K912215) | Bainbridge Laboratories, Inc. | 1991-10-04 |
| QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST (K912442) | Quidel Corp. | 1991-09-16 |
| GAP-IGG (K900343) | Biomerica, Inc. | 1991-08-22 |
| EIA FOR DETECTION OF ANTIBODIES H. PYLORI (K905409) | E-Z-Em, Inc. | 1991-06-10 |
| QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR (K905049) | Quidel Corp. | 1991-05-07 |
| PYLORI STAT TEST KIT (K904738) | Whittaker Bioproducts, Inc. | 1991-05-07 |
| PYLORI-G FIAX TEST KIT (K905468) | Whittaker Bioproducts, Inc. | 1991-05-07 |
| QUIDEL HELICOBACTER PYLORI TEST (K903099) | Quidel Corp. | 1991-04-17 |
| SELECTIVE RAPID UREA (K883641) | Remel Co. | 1989-05-04 |
| CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST (K882199) | Auspharm Intl. , Ltd. | 1988-10-06 |