119 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Chlamydia Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Shanghai Chemtron Biotech Co., Ltd.·1 device
One-Step FSH Menopause Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device
One-Step LH Ovulation Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device
Monkeypox Virus Real-time PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Carbapenem resistance gene Assay (F-PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Carbapenem resistance gene Assay (F-PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
Dynamiker SARS-CoV-2 Lyophilized RT-PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Talaromyces marneffei PCR Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Pneumocystis jirovecii (PJP) PCR Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Mucor PCR Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Candida auris PCR Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Candida PCR Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
Novel Coronavirus (2019-nCoV) RT PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
Novel Coronavirus (2019-nCoV) RT-PCR Kit (Saliva)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
MycoMDx Aspergillus PCR Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
QuicIgETM Aspergillus IgE Ab Lateral Flow Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
QuicIgGTM Candida IgG Ab Lateral Flow Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device
QuicIgGTM Aspergillus IgG Ab Lateral Flow Assay
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device