6,259 results
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41ms
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Sources: EU EUDAMED, US FDA
DGM-549
Certificate
IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·31 Basic UDI-DIs
DGM-548
Certificate
IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·33 Basic UDI-DIs
INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
INSTI COVID ANTIBODY TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV CONTROL TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
Diagnostic Kit for Calprotectin（Fluorescence Immunochromatographic Assay）
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·1 device
SARS-CoV-2 Antigen Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·1 device