635 results · 18ms · Sources: EU EUDAMED, US FDA

Bilirubin Total (Bil-T) Kit (DSA Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Bilirubin Direct Kit (DSA Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Newbio RPR 500

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·5 countries

Newbio RPR 100

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·5 countries

Newbio TPHA 1000

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·1 country

Newbio TPHA 200

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·1 country

Newbio TPHA 100

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·1 country

Newbio TPHA 1000

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·5 countries

Newbio TPHA 200

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·6 countries

Newbio TPHA 100

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·5 countries

Newbio RPR 500

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·1 country

Newbio RPR

Device
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·On the market·1 country

STA® - Dabigatran Control

Device
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·On the market·28 countries

LeukoStrat CDx FLT3 Mutation Assay

Device
EU IVDR · Eu Ivd Class C ·Invivoscribe, Inc.·On the market·11 countries

STA® - Edoxaban Control

Device
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·On the market·31 countries

sthemO Complete QC 1&2

Device
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·On the market·27 countries

sthemO Daily QC 1&2

Device
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·On the market·27 countries

STA® - ECA II

Device
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·On the market·30 countries

STA® - Liatest® D-Di PLUS

Device
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·On the market·27 countries

STA® - Edoxaban Calibrator

Device
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·On the market·27 countries