Infectious diseasesBacteriology (infect. immunology/NAT)Helicobacter pylori
H. pylori antibody assays
EMDN code W0105010402
Manufacturers registered in Europe (EUDAMED) 69
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 46
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Meridian Bioscience, Inc. Present in Europe in other categories | United States | PREMIER H. pylori Curian Analyzer ImmunoCard STAT! HpSA ImmunoCard H. pylori Curian HpSA PREMIER Platinum HpSA PLUS | K230901 (2023) |
| MARDX DIAGNOSTICS, INC. | United States | Trinity Biotech | registered |
| Techlab, Inc. Present in Europe in other categories | United States | H. PYLORI CHEK H. PYLORI QUIK CHEK QuickVue TLI H. pylori Stool Antigen Test | K181400 (2018) |
| ALFA SCIENTIFIC DESIGNS, INC. | United States | INSTANT-VIEW H. Pylori Serum Cassette Test INSTANT-VIEW H. pylori Rapid Test INSTANT-VIEW H. Pylori Whole Blood/Serum Cassette Test | K024360 (2003) |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Quest Intl., Inc. | United States | ReQuest SeraQuest | registered |
| CLARK LABORATORIES, INC. | United States | Trinity Biotech | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Gi Supply | United States | HpFast Urease HpOne | K012411 (2001) |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| Immunostics Company, Inc | United States | Detector H. pylori | registered |
| Inova Diagnostics, Inc. Present in Europe in other categories | United States | QUANTA Lite® H.pylori IgG ELISA QUANTA Lite® H.pylori IgA ELISA | K024334 (2003) |
| JANT PHARMACAL CORPORATION | – | ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived* Accutest H. Pylori Urease Rapid Test | registered |
| Quidel Corp. | United States | QuickVue | K991747 (1999) |
| TECO DIAGNOSTICS | United States | Teco Diagnostics H. Pylori Card Test | registered |
| Arj Medical, Inc. Present in Europe in other categories | United States | PyloPlus+ Rapid Urease Test | K052708 (2006) |
| BTNX Inc | – | Rapid Response | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | Icon | registered |
| Diagnostic Automation, Inc. | – | AccuDiag ™ | registered |
| Diamedix Corp. | United States | Diamedix | registered |
| Fisher Scientific Co., LLC | United States | Sure-Vue | registered |
| GERMAINE LABORATORIES, INC | United States | AIMSTEP H. PYLORI | registered |
| HARDY DIAGNOSTICS | United States | QwikID | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE | registered |
| MedMira Laboratories Inc | Canada | MedMira Rapid H. Pylori Antibody Test | K002023 (2000) |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | PRO ADVANTAGE | registered |
| Polymedco, Inc. | United States | Poly stat | registered |
| Remel Co. Present in Europe in other categories | United States | REMEL | K883641 (1989) |
| Sekisui Diagnostics, LLC Present in Europe in other categories | United States | OSOM H Pylori 25 Test Kit | registered |
| Serim Research Corp. | United States | Serim® PyloriTek® Test Kit | K014038 (2002) |
| Avanos Medical, Inc. | United States | – | registered |
| Axxin Pty Ltd | Australia | – | registered |
| BIOCHECK, INC. | United States | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Instrumentation Laboratory CO Present in Europe in other categories | United States | – | registered |
| Kenlor Industries, Inc. | United States | – | K964014 (1997) |
| LUMIQUICK DIAGNOSTICS, INC. | United States | – | registered |
| Micro Detect, Inc. | United States | – | K003794 (2001) |
| OPERON, S.A. Present in Europe in other categories | Spain | – | registered |
| Panion & BF Biotech, Inc. | Taiwan | – | K183573 (2019) |
| SST International Inc. | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Scantibodies Laboratory Inc. | United States | – | registered |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | – | registered |
| Zeus Scientific, Inc. Present in Europe in other categories | United States | – | K991820 (1999) |
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