IVDD Annex IV (excluding sections 4, 6) Expired

C-02-1088-787-22

Manufacturer: Wallac Oy
Basic UDI-DIs
48
Scopes
0
Preceding Certs
0
Risk Classes
0
Characteristics
0
Revision
Not Applicable
587
Expired 587 days ago
Expiry: October 29, 2024

Basic Information

Number
C-02-1088-787-22
Type
IVDD Annex IV (excluding sections 4, 6)
Expiry Date
October 29, 2024 Expired
Revision
Not Applicable
Manufacturer
Wallac Oy

Basic UDI-DIs

This Certificate is associated with 48 Basic UDI-DIs.

AutoDELFIA hCG

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

LifeCycle for Prenatal Screening

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress uE3

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PlGF

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress hAFP

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PlGF 1-2-3

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

AutoDELFIA Free hCGß

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PAPP-A

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PAPP-A

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress uE3

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

NeoBase Non-derivatized Assay Solutions

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

AutoDELFIA hAFP/Free hCGß Dual

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

Neonatal Phenylalanine

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress hCG kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

GSP Neonatal Phenylalanine kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

PlGF Controls

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA/AutoDELFIA Unconjugated Estriol (uE3) kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA hAFP/Free hCGß Dual

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PAPP-A

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

LifeCycle for Prenatal Screening

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

GSP Neonatal Phenylalanine kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

NeoBase 2 Non-derivatized MSMS kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

AutoDELFIA PAPP-A

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA/AutoDELFIA PlGF 1-2-3 

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PAPP-A

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

NeoBase Non-derivatized MSMS kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

NeoBase 2 Non-derivatized Assay Solutions

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

DELFIA/AutoDELFIA PAPP-A/Free hCGβ Dual DBS kit 

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress hAFP

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

LifeCycle for Prenatal Screening

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PlGF 1-2-3

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA/AutoDELFIA PlGF kit 

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress hCG kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PlGF 1-2-3

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PlGF 1-2-3

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA hAFP

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Free hCGß

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA hCG

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

AutoDELFIA Inhibin A kit 

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA PAPP-A

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

DELFIA Xpress Free hCGß

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

AutoDELFIA hAFP

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PAPP-A

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress Free hCGß

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

DELFIA Xpress PlGF

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

Neonatal Phenylalanine

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device