267 results · 17ms · Sources: EU EUDAMED, US FDA

EasyNAT GBS Assay

Device
EU IVDR · Eu Ivd Class C ·Ustar Biotechnologies (Hangzhou) Ltd.·On the market·2 countries

BIOSYNEX AMPLIFLASH GBS

Device
EU IVDR · Eu Ivd Class C ·BIOSYNEX·No longer on the market·1 country

ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)

Device
EU IVDR · Eu Ivd Class C ·RECIPE Chemicals + Instruments GmbH·On the market·32 countries

Oncotype DX Breast Recurrence Score® Kit

Device
EU IVDR · Eu Ivd Class C ·Genomic Health Inc.·On the market·31 countries

Oncotype DX Breast Recurrence Score® Kit

Device
EU IVDR · Eu Ivd Class C ·Genomic Health Inc.·On the market·31 countries

Inflammation Markers Control

Device
EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Inflammation Markers Control

Device
EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Endocrine Control

Device
EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Endocrine Control

Device
EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Tumor Marker Control

Device
EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Tumor Marker Control

Device
EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Tumor Marker Control

Device
EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Cardiac Markers Control

Device
EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Cardiac Markers Control

Device
EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Toxo IgG CLIA Microparticles

Device
EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Toxo IgM CLIA Microparticles

Device
EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CMV IgG CLIA Microparticles

Device
EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CMV IgM CLIA Microparticles

Device
EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

HSV-1 IgG CLIA Microparticles

Device
EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

HSV-1 IgM CLIA Microparticles

Device
EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries