144 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdd
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GENETIC TESTS - OTHER
Device
EU IVDD
·
Eu Ivd General
·SEASUN BIOMATERIALS Inc.·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
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
Cal-Pack 644
Device
EU IVDD
·
Eu Ivd General
·Przedsiębiorstwo Produkcji i Handlu MEDRIV sp. z o.o.·On the market
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries
Covid-19 Antigen CARD Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·On the market
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·On the market
Covid-19 Antigen CARD Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market
Covid-19 Antigen CARD Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market