Product code LYR
- Device name
- Helicobacter Pylori
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3110
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232892 | Hp Detect™ Stool Antigen ELISA | Biomerica, Inc. | 2023-12-15 |
| K230901 | Premier HpSA Flex (619096) | Meridian Bioscience, Inc. | 2023-07-03 |
| K192817 | Curian HpSA, Curian Analyzer | Meridian Bioscience, Inc. | 2020-03-13 |
| K183573 | Vstrip H. pylori Antigen Rapid Test | Panion & BF Biotech, Inc. | 2019-03-14 |
| K182559 | PREMIER Platinum HpSA PLUS | Meridian Bioscience, Inc. | 2018-11-05 |
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | DiaSorin, Inc. | 2018-08-31 |
| K181400 | H. PYLORI CHEK™ | Techlab, Inc. | 2018-08-21 |
| K181379 | H. PYLORI QUIK CHEK | Techlab, Inc. | 2018-08-21 |
| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | DiaSorin, Inc. | 2016-07-22 |
| K153661 | ImmunoCard STAT! HpSA | Meridian Bioscience, Inc. | 2016-03-14 |
| K151935 | 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 | Alere San Diego, Incorporated | 2015-08-12 |
| K141133 | 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 | BIOMERIEUX | 2015-07-09 |
| K110745 | HELICOBACTER PYLORI ELISA IGG TEST KIT | Gold Standard Diagnostics | 2012-03-02 |
| K110899 | GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT | Gold Standard Diagnostics | 2012-02-01 |
| K052716 | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT | Otsuka Pharmaceutical Co., Ltd. | 2006-11-16 |
| K052708 | PYLO-PLUS | Arj Medical, Inc. | 2006-05-01 |
| K053335 | PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 | Meridian Bioscience, Inc. | 2006-03-10 |
| K041238 | HELICOBACTER PYLORI IGG ELISA | Biohit Plc | 2004-12-13 |
| K032222 | IMMUNOCARDSTAT HPSA | Meridian Bioscience, Inc. | 2003-12-05 |
| K033067 | PYLORI IGG | Trinity Biotech USA | 2003-11-26 |
| K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | Alfa Scientific Designs, Inc. | 2003-06-10 |
| K024350 | ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE | ACON Laboratories, Inc. | 2003-04-02 |
| K024334 | QUANTA LITE H.PYLORI IGA ELISA | Inova Diagnostics, Inc. | 2003-03-27 |
| K022356 | NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY | Nichols Institute Diagnostics | 2002-10-25 |
| K014038 | PYLORITEK VP TEST KIT 5140VP | Serim Research Corp. | 2002-02-08 |
| K012588 | OXOID PYLORI TEST KIT, MODEL DR0130M | Oxoid , Ltd. | 2001-12-10 |
| K012411 | HP-ONE | Gi Supply | 2001-09-25 |
| K003794 | ELISA TEST, SEROLOGY | Micro Detect, Inc. | 2001-03-30 |
| K001177 | PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI | Enteric Products, Inc. | 2000-11-13 |
| K002023 | MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 | Medmira Laboratories, Inc. | 2000-11-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10763924750044 | Accutest H. Pylori Urease Rapid Test | JANT PHARMACAL CORPORATION | 2026-04-21 |
| 10673486013986 | Teco Diagnostics H. Pylori Card Test | TECO DIAGNOSTICS | 2026-01-27 |
| 00816576028481 | QwikID | HARDY DIAGNOSTICS | 2025-06-23 |
| 00860001810394 | PyloPlus+ Rapid Urease Test | Arj Medical, Inc. | 2025-01-29 |
| 20888277717777 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-08-08 |
| 00083059070835 | Hp Detect Stool Antigen ELISA | BIOMERICA, INC. | 2024-01-08 |
| 00612479261501 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2023-05-23 |
| 00612479261471 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2023-05-23 |
| 00848838022012 | REMEL | REMEL, INC. | 2022-12-22 |
| 20885380183642 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-23 |
| 10304040155742 | Henry Schein | HENRY SCHEIN, INC. | 2021-10-14 |
| 00612479202719 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-03-13 |
| 00612479202702 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-03-13 |
| 03573026509231 | VIDAS® H. pylori IgG | BIOMERIEUX SA | 2019-08-30 |
| M220P0800953 | PRO ADVANTAGE | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2018-09-23 |
| 10304040024154 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10743816001157 | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816001133 | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816001164 | Status™ H. pylori card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816001140 | BioSign® H. pylori card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10722355002016 | Detector H. pylori | Immunostics Company, Inc | 2016-09-22 |
| 10722355002023 | Detector H. pylori | Immunostics Company, Inc | 2016-09-22 |
| M1745140S1 | Serim® PyloriTek® Test Kit | SERIM RESEARCH CORPORATION | 2016-09-19 |
| M1745140K1 | Serim® PyloriTek® Test Kit | SERIM RESEARCH CORPORATION | 2016-09-19 |
| 05391516747714 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 05391516747721 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| M1745140K2 | Serim® PyloriTek® Test Kit | SERIM RESEARCH CORPORATION | 2016-09-19 |
| 20885380020282 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-01 |
| 08426950593256 | QUANTA Lite® H.pylori IgG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593805 | QUANTA Lite® H.pylori IgA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |