3,543 results
·
34ms
·
Sources: EU EUDAMED, US FDA
RF IgG CLIA Microparticles
Device
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·On the market·1 country
RF CLIA Microparticles
Device
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·On the market·1 country
RF IgM CLIA Microparticles
Device
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·On the market·1 country
PEPSINOGEN
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
AMYLASE - TOTAL
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
APOLIPOPROTEIN B
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
APOLIPOPROTEIN A I
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
LACTATE DEHYDROGENASE L ( LDH - L --> P )
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
CREATINE KINASE - MB ACTIVITY (CC)
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
PHOSPHATE INORGANIC / PHOSPHORUS
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
BILE ACIDS
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
CHOLINESTERASE
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
ONE STEP H. pylori Ag Test
Device
EU IVDD
·
Eu Ivd General
·InTec PRODUCTS, INC.·On the market
ONE STEP H. pylori Ag Test
Device
EU IVDD
·
Eu Ivd General
·InTec PRODUCTS, INC.·On the market
ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test
Device
EU IVDD
·
Eu Ivd General
·InTec PRODUCTS, INC.·No longer on the market
Oncotype® Sample Prep Kit
Device
EU IVDR
·
Eu Ivd Class A
·Genomic Health Inc.·On the market
Oncotype® Sample Prep Kit
Device
EU IVDR
·
Eu Ivd Class A
·Genomic Health Inc.·On the market
Oncotype DX Breast Recurrence Score® Computational Software
Device
EU IVDR
·
Eu Ivd Class C
·Genomic Health Inc.·On the market·31 countries
23andMe Personal Genome Service
Device
EU IVDD
·
Eu Ivd General
·23andMe, Inc.·No longer on the market