87 results
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9ms
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Sources: EU EUDAMED, US FDA
Specific Diagnostics
Manufacturer
🇺🇸 United States·1 Importer
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
Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·2 Importers
Healgen Scientific Limited Liability Company
Manufacturer
🇺🇸 United States·3 Importers
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
INSTI HIV ANTIBODY SELF-TEST
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·On the market·32 countries