RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

EMDN W01021699

Parent W010216 IMMUNOCHEMISTRY - RAPID TESTS & POINT OF CARE

Registry term list. Not a clinical opinion. 294 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
FT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204953	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204960	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204977	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204984	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260205042	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260205059	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260205066	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260205073	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260205080	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Gastrin 17(G-17)TestKit（Fluorescence immunochromatography method）	06976374752026	BIOBASE POCT CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GastroPanel® quick test	06419587023205	Biohit Oyj	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GastroPanel® quick test NT	06419587602417	Biohit Oyj	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GastroPanel® quick test NT	06419587602424	Biohit Oyj	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GeneSign Carbapenemase Rapid Test	06977903348017	GeneSign Biotech (Xiamen)Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
GeneSign Carbapenemase Rapid Test	06977903348024	GeneSign Biotech (Xiamen)Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Gonorrhea Antigen Rapid Test	06977412420907	Shanghai Zymetas Medtech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Gonorrhea Antigen Rapid Test	06977412420914	Shanghai Zymetas Medtech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Gonorrhea Antigen Rapid Test	06977412420921	Shanghai Zymetas Medtech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta	05944759080072	VitroBioChem SRL	Class B	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HbAlc Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260208265	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HbAlc Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260208272	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HbAlc Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260208289	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HbAlc Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260208296	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HbAlc Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260208302	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HBP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204847	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HBP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204854	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HBP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204861	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HBP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204878	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
HBP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204885	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
h-FABP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204496	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
h-FABP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204502	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
h-FABP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204519	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
h-FABP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204526	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
h-FABP Rapid Quantitative Test (Chemiluminescence Immunoassay)	06933260204533	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
High-Level Feritin Whole Blood/Serum Test	06941571810145	Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Homocysteine(HCY)TestKit（Fluorescence immunochromatography method）	06976374752194	BIOBASE POCT CO.,LTD	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. pylori Antigen Rapid Test	06977412420785	Shanghai Zymetas Medtech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. pylori Antigen Rapid Test	06977412420792	Shanghai Zymetas Medtech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
H. pylori Antigen Rapid Test	06977412420808	Shanghai Zymetas Medtech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204649	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204656	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204663	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204670	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204687	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hscTnI Rapid Quantitative Test	06933260208067	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-cTnI Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204342	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-cTnI Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204359	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-cTnI Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204366	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-cTnI Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204373	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
hs-cTnI Rapid Quantitative Test(Chemiluminescence Immunoassay)	06933260204380	Xiamen Biotime Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED