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