21 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Dengue IgG/IgM Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Immunoglobulin M (IgM) Detection Kit (Nephelometry)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Immunoglobulin M (IgM) Detection Kit (Nephelometry)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Mycoplasmal Pneumonia IgM Rapid Qualitative Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
SARS-CoV-2 IgG/IgM Control Set
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Dengue IgG/IgM and NS1 Rapid Test Device
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device
Dengue IgG/IgM and NS1 Rapid Test Device
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device
SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device
No. V1 074552 0011 Rev. 02
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs
CeCert/115/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/116/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·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/118/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·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
CeCert/120/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI