10,000 results
·
55ms
·
Sources: EU EUDAMED, US FDA
Colloidal Gold Reader
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·1 device
HIV Self Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Atomo Diagnostics Limited·1 device
AmoyDx® FFPE DNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
AmoyDx® Circulating DNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
AmoyDx® FFPE RNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
AmoyDx® Blood/Bone Marrow DNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
AmoyDx® Tissue RNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
HIV Self Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Atomo Diagnostics Limited·1 device
AmoyDx® FFPE DNA/RNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
KDHT
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Yelatma Instrument-Making Enterprise Joint-Stock Company·1 device
EDPO
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Yelatma Instrument-Making Enterprise Joint-Stock Company·11 devices
EKa(p)DH
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Yelatma Instrument-Making Enterprise Joint-Stock Company·2 devices
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBS
Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Daan Gene Co., Ltd.·1 device
Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Daan Gene Co., Ltd.·1 device
Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Daan Gene Co., Ltd.·1 device
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR