21 results
·
7ms
·
Sources: EU EUDAMED, US FDA
HEPATITIS C VIRUS - NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·On the market
HEPATITIS B VIRUS - NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·On the market
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
HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Assure Tech. (Hangzhou) Co., Ltd.·On the market
SARS-CoV-2 Antigen Rapid Tests for Self-Testing
Device
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·On the market
Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR -Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·1 device
Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·1 device
CeCert/042/W/E.1
Certificate
IVDD Annex IV Section 4·Daan Gene Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/044/W/E.1
Certificate
IVDD Annex IV Section 4·Daan Gene Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·1 device
Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·1 device
Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·1 device
CeCert/115/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/117/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/119/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
HIV Rapid Test Device (Whole blood/Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
SARS-CoV-2 Antigen Rapid Tests for Self-Testing
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
CeCert/077/W/E.1
Certificate
IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI