112 results
·
9ms
·
Sources: EU EUDAMED, US FDA
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.
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.
Sansure Biotech Inc.
Manufacturer
🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., 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
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·On the market
Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·On the market·3 countries
Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech 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.·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
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