88 results
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11ms
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Sources: EU EUDAMED, US FDA
Nucleix
Manufacturer
🇮🇱 Israel
Sanway Gene Tech. Inc.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·On the market·3 countries
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
Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·1 device
1434-IVDD-198/2022
Certificate
IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
1434-IVDD-199/2022
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
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