Home › Device types › LYR
Helicobacter Pylori
FDA product code LYR · Class 1 · Microbiology
101
Registered devices
19
Adverse events
11
Recalls
91
510(k) clearances
Devices with this code
AIMSTEP H. PYLORI — GERMAINE LABORATORIES, INCAnti-H. Pylori IgG AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.CARDINAL HEALTH — Cardinal Health 200, LLCTrinity Biotech — CLARK LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.Serim® PyloriTek® Test Kit — SERIM RESEARCH CORPORATIONAVANOS — Avanos Medical, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCTrinity Biotech — MARDX DIAGNOSTICS, INC.ReQuest — QUEST INTERNATIONAL, INC.REMEL — REMEL, INC.Anti-H. Pylori IgA AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.H. PYLORI CHEK — TECHLAB, INC.QUANTA Lite® H.pylori IgG ELISA — INOVA DIAGNOSTICS, INC.Trinity Biotech — CLARK LABORATORIES, INC.Trinity Biotech — MARDX DIAGNOSTICS, INC.AVANOS — Avanos Medical, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.ImmunoCard STAT! HpSA — MERIDIAN BIOSCIENCE, INC.H. PYLORI CHEK — TECHLAB, INC.H. PYLORI CHEK — TECHLAB, INC.AccuDiag ™ — Diagnostic Automation, Inc.GAP®-IgG (Gastritis and Peptic Ulcer Test) — BIOMERICA, INC.HpFast — GI Supply, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2023-08-25 | Immunostics, Inc. | Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard rel |
| 2003-07-31 | Diagnostic Products Corp | Kits had parts in them that did not belong in the kit. |
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