86 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Merlin Biomedical (Xiamen) Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.
SARS-CoV-2 Antigen Rapid Test Cassette
Device
EU IVDD
·
Eu Ivd Self Testing
·Merlin Biomedical (Xiamen) Co., Ltd.·On the market
SARS-CoV-2 Antigen Rapid Test Cassette
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Merlin Biomedical (Xiamen) Co., Ltd.·1 device
CeCert/037/W/E.1
Certificate
IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
bioLytical Laboratories Inc.
Manufacturer
🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S
INSTI HIV Self Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HIV-1/HIV-2 Antibody Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
iSTATIS COVID-19 Ag HOME TEST
Device
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·On the market·32 countries
iSTATIS COVID-19 Ag HOME TEST
Device
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·On the market·32 countries
iSTATIS COVID-19 Ag TEST
Device
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI COVID ANTIBODY TEST
Device
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HIV ANTIBODY SELF-TEST
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HCV CONTROL TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HIV ANTIBODY SELF-TEST
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HCV ANTIBODY TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HCV ANTIBODY TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HCV ANTIBODY TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HCV ANTIBODY TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries
INSTI HCV ANTIBODY TEST KIT
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries