1,816 results · 33ms · Sources: EU EUDAMED, US FDA

Access HBs Ab QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Beckman Coulter Inc.·1 device

Access RUBELLA IgG QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·1 device

Access HBc IgM QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Beckman Coulter Inc.·1 device

Access IL-6 QC

Basic UDI-DI
EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

Access HAV IgM QC

Basic UDI-DI
EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

DxFLEX Daily QC Fluorospheres

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

Access Hybritech PSA QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·1 device

Access Hybritech p2PSA QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·1 device

Access CMV IgM QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·1 device

Access CMV IgG QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·1 device

Access Toxo IgG QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·1 device

Access RUBELLA IgM QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·1 device

Access PAPP-A QC

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·IMMUNOTECH SAS ·1 device

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA

QBC Autoread Plus System - Dry Hematology Analyzer and Capillary Tube Centrifuge

Basic UDI-DI
EU IVDD · Eu Ivd General ·Drucker Diagnostics·1 device

Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical

FDA classification
FDA Class 1 ·Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Genesis Neurostimulation System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·ANIMAS VIBE SYSTEM

Quality Control Solution (QC Solution)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Genrui Biotech Inc.·1 device

sthemO PS VWF QC 1&2

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