Manufacturer

Innodx

ChinaLegal entities : Xiamen Innodx Biotech Co., Ltd.

Markets : Belgium · France

Approvals : EU – class A, C

EU representative : QbD RepS BV (Belgium)

11 categories, 16 models including 15 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
IVD general use consumable devices - other	W0599	Concentrated Wash Solution2 refs Diluent Universal3 refs Pre-trigger Solution2 refs Trigger Solution2 refs	A IVDR	EUDAMED record Report an error
Ebv antibodies - other	W010504040199	EBV EBNA1 IgA CLIA2 refs98/79 EBV VCA IgA CLIA2 refs98/79	– 98/79	EUDAMED record Report an error
Tb-igra (interferon-gamma-release assay)	W0105010704	TB-IGRA CLIA2 refs INNODX TB-IGRA CMIA2 refs98/79 (no longer marketed)	C IVDR, 98/79	EUDAMED record Report an error
Hav antibody (total)	W0105020102	HAV Ab CLIA2 refs98/79	– 98/79	EUDAMED record Report an error
Hav antibody igm	W0105020104	HAV IgM CLIA2 refs98/79	– 98/79	EUDAMED record Report an error
Hev antibody igg	W0105020504	HEV IgG CLIA2 refs98/79	– 98/79	EUDAMED record Report an error
Hev antibody igm	W0105020505	HEV IgM CLIA2 refs98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 CLIA2 refs98/79	– 98/79	EUDAMED record Report an error
Pipettes, tips - accessories	W0503020280	Pipette Tip PT-013 refs	A IVDR	EUDAMED record Report an error
Samples analyses, plastic containers - other accessories	W0503010280	Reaction Cup PRC-013 refs	A IVDR	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	TP Ab CLIA2 refs98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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