713 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Eu Ivd Class C
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Cancer Antigen 19-9 test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·1 device
Human Epididymis Protein 4 test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·1 device
Procalcitonin test (chemiluminescence immunoassay)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·1 device
High sensitive Cardiac Troponin-I test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·1 device
Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Chemclin Diagnostics Co., Ltd.·4 devices
Dengue NS1 Rapid Test
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Hangzhou Alltest Biotech.Co.,Ltd.·2 devices
Syphilis Rapid Test
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Hangzhou Alltest Biotech.Co.,Ltd.·9 devices
Dengue Combo Rapid Test
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Hangzhou Alltest Biotech.Co.,Ltd.·1 device
NanoTYPE 96/11 CE
Device
EU IVDR
·
Eu Ivd Class C
·Omixon Biocomputing Ltd.·On the market·12 countries
NanoTYPE 24/11 CE
Device
EU IVDR
·
Eu Ivd Class C
·Omixon Biocomputing Ltd.·On the market·12 countries
NanoTYPE 4x96/11 CE
Device
EU IVDR
·
Eu Ivd Class C
·Omixon Biocomputing Ltd.·On the market·12 countries
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
CD16-APC-Alexa Fluor 700
Device
EU IVDR
·
Eu Ivd Class C
·IMMUNOTECH SAS ·On the market·32 countries