882 results · 25ms · Sources: EU EUDAMED, US FDA

STA® - Apixaban Control

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

Optilite® Freelite Mx™ Lambda Free Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·The Binding Site Group Ltd·2 devices

Optilite® Hevylite® IgG Lambda Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·The Binding Site Group Ltd·2 devices

HbA1c

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

STA® - Apixaban Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

C-Reactive Protein Kit (Immunoturbidimetric Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Zybio Inc.·12 devices

Optilite® Hevylite® IgM Kappa Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·The Binding Site Group Ltd·2 devices

Optilite® Hevylite® IgM Lambda Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·The Binding Site Group Ltd·2 devices

Access AFP (300 & 600 Test Kit)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·2 devices

Control Serum Level 2

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Ireland Inc.·1 device

CK-MB

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Chemclin Diagnostics Co., Ltd.·4 devices

RIDA®GENE Bacterial Stool Panel I

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·R-Biopharm AG·3 devices

RIDA®GENE Bacterial Stool Panel

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·R-Biopharm AG·3 devices

RPR-DAT

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·DIESSE Diagnostica Senese S.p.A·1 device

Newbio TPHA 100

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·6 devices

Newbio RPR 100

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·4 devices

RIDA®UNITY EHEC/EPEC

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·R-Biopharm AG·1 device

STA® - Unicalibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

RIDASCREEN® Legionella

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·R-Biopharm AG·6 devices