13 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
×
EasyNAT GBS Assay
Device
EU IVDR
·
Eu Ivd Class C
·Ustar Biotechnologies (Hangzhou) Ltd.·On the market·2 countries
BIOSYNEX AMPLIFLASH GBS
Device
EU IVDR
·
Eu Ivd Class C
·BIOSYNEX·No longer on the market·1 country
BIOSYNEX AMPLIFLASH GBS
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·BIOSYNEX·1 device
EasyNAT GBS Assay
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Ustar Biotechnologies (Hangzhou) Ltd.·1 device
Tigsun GBS Antigen Rapid Test
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Beijing Tigsun Diagnostics Co., Ltd.·9 devices
CAPILLARYS 3 DBS
Device
EU IVDR
·
Eu Ivd Class A
·sebia·On the market
CAPILLARYS 3 DBS MICROPLATES
Device
EU IVDR
·
Eu Ivd Class A
·sebia·On the market
BT 1500 C/CBS
Device
EU IVDR
·
Eu Ivd Class A
·Biotecnica Instruments S.r.l.·On the market·32 countries
DBS CoreShell-Dried Blood Spot Kit
Device
EU IVDR
·
Eu Ivd Class A
·Sinopharm Allmed (Hubei) Medical Products Co., Ltd.·On the market
ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)
Device
EU IVDR
·
Eu Ivd Class C
·RECIPE Chemicals + Instruments GmbH·On the market·32 countries
ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS), non-derivatised
Device
EU IVDR
·
Eu Ivd Class C
·RECIPE Chemicals + Instruments GmbH·On the market·32 countries
ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with Filter-Plates
Device
EU IVDR
·
Eu Ivd Class C
·RECIPE Chemicals + Instruments GmbH·On the market·32 countries
ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with Filter-Plates, non-derivatised
Device
EU IVDR
·
Eu Ivd Class C
·RECIPE Chemicals + Instruments GmbH·On the market·32 countries