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CTK BIOTECH, INC.

United States·US-MF-000024900

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Aria RSV Ag Rapid Test	R0186C-20T-AR	EUDAMED	Class B	Active
OnSite® Dengue Ag Rapid Test	R0063C-10T	EUDAMED	Class C	Active
OnSite® H. pylori Ag Rapid Test	R0192C-30T	EUDAMED	Class B	Active
OnSite® H. pylori Ag Rapid Test	R0192C-20T	EUDAMED	Class B	Active
Aria® Dengue Ag Rapid Test	R0063C-20T-AR	EUDAMED	Class C	Active
Aria® Dengue Ag Rapid Test	R0063C-10T-AR	EUDAMED	Class C	Active
OnSite® H. pylori Ag Rapid Test	R0192C-50T	EUDAMED	Class B	Active
Aria® H. pylori Ag Rapid Test	R0192C-30T-AR	EUDAMED	Class B	Active
OnSite® Dengue Ag Rapid Test	R0063C	EUDAMED	Class C	Active
Aria® Dengue Ag Rapid Test	R0063C-25T-AR	EUDAMED	Class C	Active
Aria® Dengue Ag Rapid Test	R0063C-50T-AR	EUDAMED	Class C	Active
Aria® H. pylori Ag Rapid Test	R0192C-20T-AR	EUDAMED	Class B	Active
Aria® H. pylori Ag Rapid Test	R0192C-10T-AR	EUDAMED	Class B	Active
Aria Influenza A/B Ag Rapid Test	R0187C-20T-AR	EUDAMED	Class B	Active
OnSite® RSV Ag Rapid Test	R0186C	EUDAMED	Class B	Active
Aria® Dengue Ag Rapid Test	R0063C-30T-AR	EUDAMED	Class C	Active
Aria® H. pylori Ag Rapid Test	R0192C-50T-AR	EUDAMED	Class B	Active
OnSite® Dengue Ag Rapid Test	R0063C-20T	EUDAMED	Class C	Active
OnSite® H. pylori Ag Rapid Test	R0192C-10T	EUDAMED	Class B	Active
Aria® H. pylori Ag Rapid Test	R0192C-25T-AR	EUDAMED	Class B	Active
ImmuView COVID-19 Antigen Home Test	R0182CHT-2T	FDA UDI	N	Active
ImmuView COVID-19 Antigen Home Test	R0182CHT-5T	FDA UDI	N	Active
ImmuView COVID-19 Antigen Home Test	R0182CHT-20T	FDA UDI	N	Active

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