Helicobacter Pylori
FDA product code LYR · Class I (low risk) · 21 CFR 866.3110 · Microbiology
91510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Quidel Corp. 6
- Meridian Bioscience, Inc. 6
- Meridian Diagnostics, Inc. 5
- Biomerica, Inc. 3
- DiaSorin, Inc. 2
- Chemtrak, Inc. 2
- Micro Detect, Inc. 2
- Serim Research Corp. 2
- Schiff & Co. 2
- Zeus Scientific, Inc. 2
- Gi Supply 2
- Orion Diagnostica, Div. Orion Corp. 2
- Smithkline Diagnostics, Inc. 2
- Biomerieux Inc 2
- Enteric Products, Inc. 2
- Inova Diagnostics, Inc. 2
- Hycor Biomedical, Inc. 2
- Gold Standard Diagnostics 2
- E-Z-Em, Inc. 2
- Whittaker Bioproducts, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232892 | Hp Detect Stool Antigen ELISALYR · Traditional | Biomerica, Inc. | 12/15/2023SE |
| K230901 | Premier HpSA Flex (619096)LYR · Traditional | Meridian Bioscience, Inc. | 07/03/2023SE |
| K192817 | Curian HpSA, Curian AnalyzerLYR · Traditional | Meridian Bioscience, Inc. | 03/13/2020SE |
| K183573 | Vstrip H. pylori Antigen Rapid TestLYR · Traditional | Panion & BF Biotech, Inc. | 03/14/2019SE |
| K182559 | PREMIER Platinum HpSA PLUSLYR · Traditional | Meridian Bioscience, Inc. | 11/05/2018SE |
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetLYR · Traditional | DiaSorin, Inc. | 08/31/2018SE |
| K181400 | H. Pylori ChekLYR · Traditional | Techlab, Inc. | 08/21/2018SE |
| K181379 | H. Pylori Quik ChekLYR · Traditional | Techlab, Inc. | 08/21/2018SE |
| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetLYR · Traditional | DiaSorin, Inc. | 07/22/2016SE |
| K153661 | ImmunoCard STAT! HpSALYR · Traditional | Meridian Bioscience, Inc. | 03/14/2016SE |
| K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood…LYR · Special | Alere San Diego, Incorporated | 08/12/2015SE |
| K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…LYR · Traditional | Biomerieux | 07/09/2015SE |
| K110745 | Helicobacter Pylori Elisa Igg Test KitLYR · Traditional | Gold Standard Diagnostics | 03/02/2012SE |
| K110899 | Gold Standard Diagnostics H. Pylori Elisa Iga Test KitLYR · Traditional | Gold Standard Diagnostics | 02/01/2012SE |
| K052716 | Rapirun H. Pylori Antibody Detection KitLYR · Traditional | Otsuka Pharmaceutical Co., Ltd. | 11/16/2006SE |
| K052708 | Pylo-PlusLYR · Traditional | Arj Medical, Inc. | 05/01/2006SE |
| K053335 | Premier Platinum Hpsa Plus, Models 601396, 601480LYR · Traditional | Meridian Bioscience, Inc. | 03/10/2006SE |
| K041238 | Helicobacter Pylori Igg ElisaLYR · Traditional | Biohit Plc | 12/13/2004SE |
| K032222 | Immunocardstat HpsaLYR · Traditional | Meridian Bioscience, Inc. | 12/05/2003SE |
| K033067 | Pylori IggLYR · Traditional | Trinity Biotech USA | 11/26/2003SE |
| K024360 | Instant-View H. Pylori One Step Rapid TestLYR · Traditional | Alfa Scientific Designs, Inc. | 06/10/2003SE |
| K024350 | Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test DeviceLYR · Traditional | ACON Laboratories, Inc. | 04/02/2003SE |
| K024334 | Quanta Lite H.Pylori Iga ElisaLYR · Traditional | Inova Diagnostics, Inc. | 03/27/2003SE |
| K022356 | Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies ImmunoassayLYR · Traditional | Nichols Institute Diagnostics | 10/25/2002SE |
| K014038 | Pyloritek VP Test Kit 5140VPLYR · Traditional | Serim Research Corp. | 02/08/2002SE |
| K012588 | Oxoid Pylori Test Kit, Model DR0130MLYR · Traditional | Oxoid , Ltd. | 12/10/2001SE |
| K012411 | Hp-OneLYR · Traditional | Gi Supply | 09/25/2001SE |
| K003794 | Elisa Test, SerologyLYR · Traditional | Micro Detect, Inc. | 03/30/2001SE |
| K002023 | Medmira Rapid H. Pylori Antibody Test, Model 10714LYR · Traditional | Medmira Laboratories, Inc. | 11/13/2000SE |
| K001177 | Pp-Cap Eia for the Detection of Iga Antibodies to H. PyloriLYR · Traditional | Enteric Products, Inc. | 11/13/2000SE |
| K001460 | Vidas H. Pylori Igg (Hpy) Assay, Model 30 192LYR · Traditional | bioMerieux, Inc. | 10/04/2000SE |
| K002451 | Modification to: Pronto DryLYR · Traditional | Medical Instruments Corporation, AG | 09/29/2000SE |
| K000463 | Immulite H. Pylori Igg and Immulite 2000 H. Pylori IggLYR · Traditional | Diagnostic Products Corp. | 06/01/2000SE |
| K991697 | Uni-Gold H. PyloriLYR · Traditional | Trinity Biotech, Plc | 12/21/1999SE |
| K990462 | Is H. Pylori Igg Elisa Test SystemLYR · Traditional | Columbia Bioscience, Inc. | 09/03/1999SE |
| K991820 | Helicobacter Pylori Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay…LYR · Traditional | Zeus Scientific, Inc. | 08/12/1999SE |
| K991747 | Quickvue One-Step H. Pylori II TestLYR · Traditional | Quidel Corp. | 08/04/1999SE |
| K991248 | Pronto DryLYR · Traditional | Medical Instruments Corporation Mic AG | 06/22/1999SE |
| K984544 | The Aptus (Automated) Application of the Hm-Cap Eia Kit. an Enzyme Linked Immunosorbent…LYR · Traditional | Enteric Products, Inc. | 02/18/1999SE |
| K983255 | Modification to: Premier Platinum HpsaLYR · Traditional | Meridian Diagnostics, Inc. | 12/17/1998SE |
| K982362 | Abbott Testpack Plus H. PyloriLYR · Traditional | Abbott Laboratories | 11/18/1998SE |
| K982790 | Quanta Lite H. Pylori Igg ElisaLYR · Traditional | Inova Diagnostics, Inc. | 11/04/1998SE |
| K980798 | Biosign H. Pylori Wb-New One-Step Anti-H. Pylori Antibody TestLYR · Traditional | Princeton BioMeditech Corp. | 09/22/1998SE |
| K980782 | Stat-Simple PyloriLYR · Traditional | Saliva Diagnostic Systems, Inc. | 08/05/1998SE |
| K981396 | PyloriprobeLYR · Traditional | Amdl, Inc. | 07/30/1998SE |
| K980821 | Helicobacter Pylori Igg Elisa Test SystemLYR · Traditional | Zeus Scientific, Inc. | 07/30/1998SE |
| K980076 | Premier Platinum HpsaLYR · Traditional | Meridian Diagnostics, Inc. | 05/12/1998SE |
| K972981 | Shield HELICO-G2 Elisa KitLYR · Traditional | Shield Diagnostics, Ltd. | 03/17/1998SE |
| K973508 | Pylori Detect IggLYR · Traditional | Micro Detect, Inc. | 03/10/1998SE |
| K973523 | Accustat H. Pylori One Step TestLYR · Traditional | Boehringer Mannheim Corp. | 03/03/1998SE |
| K972146 | Qualitrol Unassayed H. Pylori Control Set Positive and Negative ControlsLYR · Traditional | Consolidated Technologies, Inc. | 07/08/1997SE |
| K971537 | Pyloriset Eia-G (68926)LYR · Traditional | Orion Diagnostica, Div. Orion Corp. | 06/27/1997SE |
| K964014 | Kenlor H. Pylori Control SerumLYR · Traditional | Kenlor Industries, Inc. | 03/03/1997SE |
| K965099 | Accumeter H. Pylori TestLYR · Traditional | Chemtrak, Inc. | 02/20/1997SE |
| K964675 | H.Pylori ControlsLYR · Traditional | Pyramid Biological Corp. | 01/27/1997SE |
| K961508 | Immunocard H. PyloriLYR · Traditional | Meridian Diagnostics, Inc. | 01/21/1997SE |
| K952220 | Meretek Breath Test for H.Pylori Collection KitLYR · Traditional | Meretek Diagnostics, Inc. | 09/17/1996SE |
| K953873 | Varelisa Helicobacter Pylori AntibodiesLYR · Traditional | Elias U.S.A., Inc. | 08/30/1996SE |
| K961221 | Pylori Igg Elisa Test SystemLYR · Traditional | Armkel, LLC | 07/30/1996SE |
| K960478 | Accumeter H. Pylori TestLYR · Traditional | Chemtrak, Inc. | 06/27/1996SE |
| K960183 | Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for…LYR · Traditional | Smithkline Diagnostics, Inc. | 06/07/1996SE |
| K953686 | Helisal Rapid Blood TestLYR · Traditional | Cortecs, Ltd. | 05/21/1996SE |
| K955085 | Hm-Cap Eia Test (Modification)LYR · Traditional | Schiff & Co. | 02/09/1996SE |
| K952517 | Quickvue One-Step Helicobactor Pylori TestLYR · Traditional | Quidel Corp. | 02/06/1996SE |
| K954926 | Hm-Cap Control PanelLYR · Traditional | E-Z-Em, Inc. | 01/30/1996SE |
| K953632 | Serim Pyloritek Test KitLYR · Traditional | Serim Research Corp. | 12/18/1995SE |
| K944159 | Hm-Cap Eia KitLYR · Traditional | Schiff & Co. | 07/18/1995SE |
| K943513 | PS IILYR · Traditional | Washington Biotechnology | 05/11/1995SE |
| K944903 | Hp-FastLYR · Traditional | Gi Supply | 04/20/1995SE |
| K942974 | Pyloriset DryLYR · Traditional | Orion Diagnostica, Div. Orion Corp. | 04/05/1995SE |
| K945558 | Premier(Tm) H. PyloryLYR · Traditional | Meridian Diagnostics, Inc. | 03/03/1995SE |
| K941560 | Immunocard H. PyloriLYR · Traditional | Meridian Diagnostics, Inc. | 12/08/1994SE |
| K934863 | Flexsure HPLYR · Traditional | Smithkline Diagnostics, Inc. | 05/18/1994SE |
| K924689 | Ubi Magiwel(Tm) Helicobacter Pylori IggLYR · Traditional | United Biotech, Inc. | 08/10/1993SE |
| K925190 | PyloriscreenLYR · Traditional | New Horizons Diagnostics Co. | 03/23/1993SE |
| K923445 | Pyloragen Helicbacter Pylori Test Kit - ModifiedLYR · Traditional | Hycor Biomedical, Inc. | 09/11/1992SE |
| K920827 | Amrad Hel-PtestLYR · Traditional | Amrad | 07/14/1992SE |
| K915185 | Gap Igg H.Pylori ModifiedLYR · Traditional | Biomerica, Inc. | 03/04/1992SE |
| K915851 | Quidel Quickvue H. Pylori Controls (Pos. and Neg)LYR · Traditional | Quidel Corp. | 02/21/1992SE |
| K904655 | PylorisetLYR · Traditional | Orion Diagnostica, Inc. | 10/21/1991SE |
| K912255 | Hycor Pyloragen Helicobacter Pylori TestLYR · Traditional | Hycor Biomedical, Inc. | 10/11/1991SE |
| K912215 | PyloritrakLYR · Traditional | Bainbridge Laboratories, Inc. | 10/04/1991SE |
| K912442 | Quidel Helicobacter Pylori Microwell Eia TestLYR · Traditional | Quidel Corp. | 09/16/1991SE |
| K900343 | Gap-IggLYR · Traditional | Biomerica, Inc. | 08/22/1991SE |
| K905409 | Eia for Detection of Antibodies H. PyloriLYR · Traditional | E-Z-Em, Inc. | 06/10/1991SE |
| K905468 | Pylori-G Fiax Test KitLYR · Traditional | Whittaker Bioproducts, Inc. | 05/07/1991SE |
| K905049 | Quidel Helicobacter Pylori Postive/Negative ContrLYR · Traditional | Quidel Corp. | 05/07/1991SE |
| K904738 | Pylori Stat Test KitLYR · Traditional | Whittaker Bioproducts, Inc. | 05/07/1991SE |
| K903099 | Quidel Helicobacter Pylori TestLYR · Traditional | Quidel Corp. | 04/17/1991SE |
| K883641 | Selective Rapid UreaLYR · Traditional | Remel Co. | 05/04/1989SE |
| K882199 | Clotest, Campylobacter Pylori Urease Enzyme TestLYR · Traditional | Auspharm Intl. , Ltd. | 10/06/1988SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0794-2026 Class II | Peptic Ulcer Test (H, pylori)Distribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0739-2026 Class II | H pylori (Peptic ulcer) TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0702-2024 Class II | Detector H. Pylori, Catalog Number IHP-30Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct… | Immunostics, Inc. | 08/25/2023Open, Classified |
| Z-0864-2023 Class II | VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-0799-2023 Class II | VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-0797-2023 Class II | VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-1635-2011 | H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | BioCheck Inc | 12/22/2010Terminated |
| Z-0996-2010 | H. Pylori IgM ELISA 96 Well Kit, Catalog Number: HP015M The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | Calbiotech Inc | 08/27/2008Terminated |
| Z-0995-2010 | H. Pylori IgA ELISA 96 Well Kit, Catalog Number: HP014A The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | Calbiotech Inc | 08/27/2008Terminated |