28 results
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17ms
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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
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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
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
hyborg Dx RED2
Device
EU IVDR
·
Eu Ivd Class A
·Cube Dx GmbH·On the market·32 countries
PE-Buffer
Device
EU IVDR
·
Eu Ivd Class A
·Cube Dx GmbH·On the market·32 countries
Rack
Device
EU IVDR
·
Eu Ivd Class A
·Cube Dx GmbH·On the market·32 countries
Waste Bottle
Device
EU IVDR
·
Eu Ivd Class A
·Cube Dx GmbH·On the market·32 countries
System Liquid
Device
EU IVDR
·
Eu Ivd Class A
·Cube Dx GmbH·On the market·32 countries
TRUPCR® Bacterial / Fungal DNA Extraction Kit
Device
EU IVDR
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Eu Ivd Class A
·3B BlackBio Dx Limited·On the market
TRUPCR® Bacterial / Fungal DNA Extraction Kit
Device
EU IVDR
·
Eu Ivd Class A
·3B BlackBio Dx Limited·On the market
TRUPCR® Total Nucleic Acid Extraction Kit (500µl)
Device
EU IVDR
·
Eu Ivd Class A
·3B BlackBio Dx Limited·On the market
TRUPCR® BS DNA Extraction Kit
Device
EU IVDR
·
Eu Ivd Class A
·3B BlackBio Dx Limited·On the market
TRUPCR® Panel Extraction Kit
Device
EU IVDR
·
Eu Ivd Class A
·3B BlackBio Dx Limited·On the market
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