14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
×
GenomEra CDX Software
Device
EU IVDR
·
Eu Ivd Class A
·Uniogen Oy·On the market
GenomEra CDX System
Device
EU IVDR
·
Eu Ivd Class A
·Uniogen Oy·On the market
LeukoStrat CDx FLT3 Mutation Assay
Device
EU IVDR
·
Eu Ivd Class C
·Invivoscribe, Inc.·On the market·11 countries
LeukoStrat CDx FLT3 Mutation Assay
Device
EU IVDR
·
Eu Ivd Class C
·Invivoscribe, Inc.·No longer on the market·11 countries
BLOOD COLLECTION, CAPILLARY TUBES
Device
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·On the market
BUFFERS
Device
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·On the market
CDX-2 & CEA Multiplex Cocktail; Clones EP25 & COL-1 (Ready-To-Use) 25 mL
Device
EU IVDR
·
Eu Ivd Class C
·ScyTek Laboratories Inc.·On the market·1 country
CDX-2 & CEA Multiplex Cocktail; Clones EP25 & COL-1 (Ready-To-Use) 7 mL
Device
EU IVDR
·
Eu Ivd Class C
·ScyTek Laboratories Inc.·On the market·1 country
GenomEra CDX System
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Uniogen Oy·2 devices
LeukoStrat CDx FLT3 Mutation Assay
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Invivoscribe, Inc.·2 devices
Automatic Hematology Analyzer DD-5 Fluorescent Dye A
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Maccura Biotechnology Co., Ltd. ·1 device
Standard anti-Tg IgG - Standard anti-Tg IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·ABD SRL·1 device
EDTA Capillary Tubes
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Chase Buffer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device