8,371 results · 62ms · Sources: EU EUDAMED, US FDA

Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)

Device
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·On the market

Leukemia BCR-ABL Fusion Gene Typing Real Time RT-PCR Kit

Device
EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·On the market

Loopamp™ Malaria Pv Detection Kit

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·1 country

Loopamp™ Malaria Pf Detection Kit

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·1 country

Loopamp™ Malaria Pan Detection Kit

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·1 country

Loopamp™ Malaria Pan Detection Kit

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·1 country

OC-SENSOR FIT Latex Reagent (for OC-SENSOR DIANA, PLEDIA)

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·5 countries

OC-SENSOR FIT Latex Reagent (for OC-SENSOR Micro)

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·1 country

OC-Light™ S FIT Sampling Bottles

Device
EU IVDR · Eu Ivd Class A ·EIKEN CHEMICAL CO., LTD.·On the market·1 country

OC-FCa Calibrator

Device
EU IVDR · Eu Ivd Class B ·EIKEN CHEMICAL CO., LTD.·On the market·2 countries

OC-FIT Calibrator for OC-SENSOR Ceres

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·2 countries

Loopamp™ MTBC Detection Kit

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·1 country

OC-FCa Control LV3

Device
EU IVDR · Eu Ivd Class B ·EIKEN CHEMICAL CO., LTD.·On the market·2 countries

OC-FCa Control LV2

Device
EU IVDR · Eu Ivd Class B ·EIKEN CHEMICAL CO., LTD.·On the market·2 countries

OC-FCa Control LV1

Device
EU IVDR · Eu Ivd Class B ·EIKEN CHEMICAL CO., LTD.·On the market·2 countries

OC-FCa Reagent (OC-SENSOR Ceres)

Device
EU IVDR · Eu Ivd Class B ·EIKEN CHEMICAL CO., LTD.·On the market·2 countries

OC-FCa Reagent (OC-SENSOR PLEDIA)

Device
EU IVDR · Eu Ivd Class B ·EIKEN CHEMICAL CO., LTD.·On the market·2 countries

OC-SENSOR Sample Diluent (For OC-SENSOR Ceres)

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·2 countries

OC-FIT Control LV2

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·5 countries

OC-SENSOR Sample Diluent

Device
EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·On the market·3 countries