H. PYLORI ANTIBODY ASSAYS

EMDN W0105010402

Registry term list. Not a clinical opinion. 137 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
Helicobacter Pylori (H.Pylori) Typing Test Kit (QDs Immunofluorescence Method)	36974969794773	Chongqing iSIA BIO-Technology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Helicobacter pylori IgA ELISA	04049325002340	IBL International GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Helicobacter pylori IgG	+ENTI301140460F	Gold Standard Diagnostics Frankfurt GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 IgG	06419587010403	Biohit Oyj	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Helicobacter pylori IgG antibody test kit (LFA)	06930317871496	Dynamiker Biotechnology (Tianjin) Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Helicobacter pylori IgG ELISA	04049325002357	IBL International GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Helicobacter Pylori IgG (HP IgG) Detection Kit(CLIA)	06974674893012	Shenzhen Zijian Biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Helicobacter pylori IgG plus	+ENTI301140480H	Gold Standard Diagnostics Frankfurt GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Helicobacter pylori IgM	+ENTI302193020G	Gold Standard Diagnostics Frankfurt GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Helicobacter pylori IgM ELISA	04049325002364	IBL International GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Helicobacter Pylori Urease Antibody (Urease Ab) Assay Kit (Chemiluminescent Immunoassay)	06942028502286	Sichuan Orienter Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HELICOBACTER PYLORI VIRCLIA® IgA MONOTEST	08436040326602	Vircell, S.L	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HELICOBACTER PYLORI VIRCLIA® IgG MONOTEST	08436040326329	Vircell, S.L	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HP IgG Test Kit (CLIA Method)	56974969796757	Chongqing iSIA BIO-Technology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HP Typing Test Kit (CLIA Method)	36974969796883	Chongqing iSIA BIO-Technology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HP Typing Test Kit (CLIA Method)	56974969796887	Chongqing iSIA BIO-Technology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. Pylori	05404035100684	Cypress Diagnostics	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. Pylori Ab FIA Kit	06974674892381	Shenzhen Zijian Biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Ab Rapid Test Device(Whole blood/Serum/Plasma)	06976753475058	Hangzhou Cybereagen Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. pylori Antibody Rapid Test	06952804831967	Assure Tech. (Hangzhou) Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. pylori Antibody Rapid Test	06974408029571	Hangzhou Fanttest Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. pylori Antibody Rapid Test	16972698601382	Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.pylori Antibody Rapid Test Kit	06942293580323	Beijing Diagreat Biotechnologies Co., Ltd.	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma)	06974785750464	Anhui Formaster Biosci Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062700067	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062771692	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062771708	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062771715	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062773238	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062773245	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062773252	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062773269	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062773276	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori Antibody Test Kit	06952062773283	ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. pylori (HP) Antibody Rapid Test Device(Serum/Plasma)	06976753475508	Hangzhou Cybereagen Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H.Pylori IgG-CLIA	36974969796753	Chongqing iSIA BIO-Technology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
IMMULITE 2000 H. pylori IgG	00630414961637	Siemens Healthcare Diagnostics Products Ltd.	Class B	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
IMMULITE 2000 H. pylori IgG	00630414961644	Siemens Healthcare Diagnostics Products Ltd.	Class B	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
K-ASSAY H. pylori	00816426021136	KAMIYA BIOMEDICAL COMPANY, LLC	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
K-ASSAY H. pylori Calibrator	00816426021143	KAMIYA BIOMEDICAL COMPANY, LLC	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
K-ASSAY H. pylori Control	00816426021150	KAMIYA BIOMEDICAL COMPANY, LLC	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Laboquick	08699195610433	Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.	Class B	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LYHER	06972412615148	Hangzhou Laihe Biotech Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
LYHER	06972412618262	Hangzhou Laihe Biotech Co., Ltd.	Class B	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Microblot-Array Helicobacter IgA	08595635310577	TestLine Clinical Diagnostics s.r.o.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Microblot-Array Helicobacter IgG	08595635310584	TestLine Clinical Diagnostics s.r.o.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MP Diagnostics Helico Blot 2.1	08887581000252	MP Biomedicals Asia Pacific Pte Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
MP Diagnostics Helico Blot 2.1	08887581000269	MP Biomedicals Asia Pacific Pte Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
NovaLisa® Helicobacter pylori IgG	+ENTIHELG02200P	Gold Standard Diagnostics Frankfurt GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
NovaLisa® Helicobacter pylori IgG	+ENTIHELG0220DS0N	Gold Standard Diagnostics Frankfurt GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED