88 results
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8ms
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Sources: EU EUDAMED, US FDA
V1 003496 007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
V1 003469 0007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
V1 003496 0007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·24 Basic UDI-DIs
V1 0034960007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
CE 651490
Certificate
MDD Annex II (excluding section 4)·Micropace Pty Ltd·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE 651409
Certificate
MDD Annex II (excluding section 4)·AtCor Medical Pty Ltd·BSI Group The Netherlands B.V.·3 Basic UDI-DIs
ZENA MAX Human Factor II Prothrombin “20210 Mutation” Real Time PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
GeneFix DNA/RNA Collector, Non-sterile
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Cell Projects Ltd·46 devices
Inoclic
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Pro-Lab Diagnostics UK·7 devices
Factor XIII
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·KAMIYA BIOMEDICAL COMPANY, LLC·3 devices
ZENA MAX Human Herpesvirus 8 (HHV-8) Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
ZENA MAX Human Herpesvirus 6 (HHV-6) Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
ZENA MAX HSV Type 1/2 Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
ZENA MAX Papillomavirus (HPV) Type 16 and 18 Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
ZENA MAX Papillomavirus (HPV) Type 6 and 11 Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
ZENA MAX Hepatitis E Virus Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
ZENA MAX Hepatitis A Virus Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
ZENA MAX BK Virus Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
ZENA MAX Dengue Virus Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device
ZENA MAX Measles Virus Real Time PCR Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Advanced Molecular Diagnostics Ltd·1 device