626 results
·
9ms
·
Sources: EU EUDAMED, US FDA
2019-nCOV IgG Antibody kit (Chemiluminescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
2019-nCOV IgM Antibody kit (Chemiluminescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
Integrated Nucleic Acid Testing Device
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Guangzhou Pluslife Biotech Co., Ltd·1 device
CE-MDD-0082/09/2020/01
Certificate
MDD Annex II (excluding section 4)·Laboratories Hyamed SA·BSI Group The Netherlands B.V.·3 Basic UDI-DIs
CE-MDD-0082/09/2020/01/DD.01
Certificate
MDD Annex II Section 4·Laboratories Hyamed SA·BSI Group The Netherlands B.V.·3 Basic UDI-DIs
CeCert/113/W/E.1
Certificate
IVDD Annex III Section 6·Dynamiker Biotechnology (Tianjin) Co., Ltd.·CeCert Sp. z o.o.·2 Basic UDI-DIs