15 results
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25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
×
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
ROTAVIRUS RAPID TEST CASSETTE (FECES)
Device
EU IVDR
·
Eu Ivd Class A
·Tody Laboratories Int. SRL·On the market
AFP RAPID TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA)
Device
EU IVDR
·
Eu Ivd Class A
·Tody Laboratories Int. SRL·On the market
TSH RAPID TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA)
Device
EU IVDR
·
Eu Ivd Class A
·Tody Laboratories Int. SRL·On the market
ADENOVIRUS RAPID TEST CASSETTE (FECES)
Device
EU IVDR
·
Eu Ivd Class A
·Tody Laboratories Int. SRL·On the market
CEA RAPID TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA)
Device
EU IVDR
·
Eu Ivd Class A
·Tody Laboratories Int. SRL·On the market
URINE STRIPS READER - 50S
Device
EU IVDR
·
Eu Ivd Class A
·Tody Laboratories Int. SRL·On the market
URINE STRIPS READER - S300
Device
EU IVDR
·
Eu Ivd Class A
·Tody Laboratories Int. SRL·On the market
LeukoStrat CDx FLT3 Mutation Assay
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Invivoscribe, Inc.·2 devices
Urine Strips Reader
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Tody Laboratories Int. SRL·2 devices
RAPID TEST CASSETTE
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Tody Laboratories Int. SRL·5 devices
Hypertension Multi Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices
FIT NS-Prime Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Alfresa Pharma Corporation·1 device
FIT NS-Prime Specimen Diluent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Alfresa Pharma Corporation·1 device