35 results
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8ms
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Sources: EU EUDAMED, US FDA
HBsAg Rapid Test Cassette
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Hangzhou Alltest Biotech.Co.,Ltd.·1 device
HBsAg Rapid Test Cassette
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Hangzhou Alltest Biotech.Co.,Ltd.·1 device
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·1 device
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·1 device
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·1 device
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·1 device
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·1 device
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·1 device
CeCert/097/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Hangzhou Alltest Biotech.Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/091/W/E.1
Certificate
IVDD Annex III Section 6·Shenzhen Microprofit Biotech Co., Ltd.·CeCert Sp. z o.o.·3 Basic UDI-DIs
CeCert/092/W/E.2
Certificate
IVDD Annex III Section 6·Shenzhen Microprofit Biotech Co., Ltd.·CeCert Sp. z o.o.·3 Basic UDI-DIs
CeCert/102/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Hangzhou Alltest Biotech.Co.,Ltd.·CeCert Sp. z o.o.·4 Basic UDI-DIs
CeCert/086/W/E.1
Certificate
IVDD Annex III Section 6·Shenzhen Zijian Biotechnology Co., Ltd·CeCert Sp. z o.o.·2 Basic UDI-DIs