1,816 results
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33ms
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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