28 results
·
15ms
·
Sources: EU EUDAMED, US FDA
A113 Anti-HBc IgM
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·LGC Clinical Diagnostics, Inc.·1 device
ACCURUN 141 Rubella IgM Positive Control
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·1 device
Multichem ID Rubella IgM Positive Control
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·1 device
ACCURUN 136 Toxoplasma IgM Positive Control
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·1 device
ACCURUN 121 HAV IgM Positive Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·LGC Clinical Diagnostics, Inc.·1 device
ACCURUN 121 HAV IgM Positive Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·LGC Clinical Diagnostics, Inc.·1 device
ACCURUN 31 EBV IgM Positive Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·LGC Clinical Diagnostics, Inc.·1 device
ACCURUN 146 CMV IgM Positive Control
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·1 device
Multichem ID ToRC IgM Positive Control
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·1 device
ACCURUN 132 Borrelia burgdorferi IgM Positive Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·LGC Clinical Diagnostics, Inc.·1 device
ACCURUN Anti-SARS-CoV-2 IgM Controls Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·LGC Clinical Diagnostics, Inc.·1 device
ACCURUN 26 ToRC IgM Positive Control Series 5000
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·LGC Clinical Diagnostics, Inc.·1 device
28620136171
Certificate
MDR QMS·Eyenuk, Inc.·Intertek Medical Notified Body AB
41302127-00
Certificate
MDD Annex II (excluding section 4)·Eyenuk, Inc.·INTERTEK SEMKO AB·1 Basic UDI-DI
10000360569-PA-NA-USA
Certificate
MDD Annex II Section 4·Vycor Medical Inc.·DNV Product Assurance AS·1 Basic UDI-DI
10000360569-PA-NA-USA
Certificate
MDD Annex II Section 4·Vycor Medical Inc.·DNV Product Assurance AS·25 Basic UDI-DIs
41314934-05
Certificate
MDD Annex II (excluding section 4)·NorthEast Monitoring, Inc.·INTERTEK SEMKO AB·3 Basic UDI-DIs
575325
Certificate
IVDD Annex IV (excluding sections 4, 6)·LGC Clinical Diagnostics, Inc.·BSI Group The Netherlands B.V.·6 Basic UDI-DIs
CE 575325
Certificate
IVDD Annex IV (excluding sections 4, 6)·LGC Clinical Diagnostics, Inc.·BSI Group The Netherlands B.V.·12 Basic UDI-DIs
3822623
Certificate
IVDD Annex IV (excluding sections 4, 6)·LGC Clinical Diagnostics, Inc.·DEKRA Certification B.V.·133 Basic UDI-DIs