86 results
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17ms
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Sources: EU EUDAMED, US FDA
COMPLEMENT COMPONENT C3/C3C
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Amoy Diagnostics Co., LTD.·On the market
Complement Components C3 Kit (Immunoturbidimetric Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·1 device
AmoyDx® KRAS/NRAS Mutations Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Amoy Diagnostics Co., LTD.·1 device
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