102 results
·
15ms
·
Sources: EU EUDAMED, US FDA
InTec PRODUCTS, INC.
Manufacturer
🇨🇳 China·25 Basic UDI-DIs·25 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
Atomo Diagnostics Limited
Manufacturer
🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.
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.
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
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
Simplitude ByMe
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Atomo Diagnostics Limited·On the market·7 countries
Simplitude ByMe
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Atomo Diagnostics Limited·On the market·7 countries
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
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
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