506 results
·
60ms
·
Sources: EU EUDAMED, US FDA
T-SPOT.CMV
Device
EU IVDD
·
Eu Ivd General
·Oxford Immunotec Ltd·On the market
GSP NEONATAL IRT KIT (3306-001U)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NeoBase 2 Non-derivatized MSMS Kit
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NeoLSD MSMS kit
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GSP NEONATAL THYROXINE (T4)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GSP NEONATAL TOTAL GALACTOSE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUTODELFIA NEONATAL IRT KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Wallac Oy
Importer
🇫🇮 Finland·1 Manufacturer
C-02-1088-787-22
Certificate
IVDD Annex IV (excluding sections 4, 6)·Wallac Oy·Eurofins Electric & Electronics Finland Oy·48 Basic UDI-DIs
sFlt-1 Controls
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Wallac Oy·1 device
Vanadis Core T21/T18/T13 Reagent Cartridge
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·1 device
Vanadis Core T21/T18/T13 Reagent Cartridge
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·1 device
Vanadis View Plate
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Wallac Oy·1 device
Vanadis Core Buffer kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Wallac Oy·1 device
Vanadis Extract Bind and Wash kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Wallac Oy·1 device
Vanadis Extract Reagent kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Wallac Oy·1 device
chemagic Prepito-D
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Wallac Oy·1 device
Neonatal GALT
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Wallac Oy·1 device
Neonatal GALT
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Wallac Oy·1 device
GSP Neonatal GALT kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Wallac Oy·1 device