2,654 results
·
40ms
·
Sources: EU EUDAMED, US FDA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·llesto 7 VT-T / 5 VR-T , 7 VR-T DX; Ifora 7 VR-T /5 VR-T /7 VR-T DX , 5 VR-T DX ; Itrevia 7 VT-T/ DX (GBLi), Intica 5 VR
hybcell Bacteria DNA xB
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
hybcell Fungi DNA xB
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
hybcell Pathogens DNA xB
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
PCR-Box Bacteria
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
PCR-Box Fungi
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
PCR-Box Resistance
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
LINA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
IPC
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
GINA 500
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
GINA 500 + DNA purification
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
PCR-Box IPC
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Cube Dx GmbH·1 device
hyborg Dx RED2
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Cube Dx GmbH·5 devices
Hydropump
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DX Products Limited·45 devices
0425-MED-003637-00
Certificate
MDD Annex II (excluding section 4)·D.Z. MEDICALE S.R.L.·ICIM S.P.A.·11 Basic UDI-DIs
0425-;MED-003637-00
Certificate
MDD Annex II (excluding section 4)·D.Z. MEDICALE S.R.L.·ICIM S.P.A.·1 Basic UDI-DI
CE:0425-MED-003637-00
Certificate
MDD Annex II (excluding section 4)·D.Z. MEDICALE S.R.L.·ICIM S.P.A.·1 Basic UDI-DI
TRUPCR® Bacterial / Fungal DNA Extraction Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·3B BlackBio Dx Limited·2 devices
TRUPCR® Total Viral Nucleic Acid Extraction Kit (500µl)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·3B BlackBio Dx Limited·1 device