9,675 results
·
43ms
·
Sources: EU EUDAMED, US FDA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBeAg
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBcAg
CMV Cytomegalovirus Antibody IgM Rapid Test Kit(Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Qingdao Hightop Biotech Co., Ltd.·1 device
CMV Cytomegalovirus Antibody IgM/IgG Rapid Test (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Qingdao Hightop Biotech Co., Ltd.·1 device
TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Qingdao Hightop Biotech Co., Ltd.·1 device
Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Anti-E monoclonal, human IgM clones: MS-258, 906
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·ANTITOXIN GmbH·1 device
Anti-C monoclonal, human IgM clones: MS-24, P3X25513G8
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·ANTITOXIN GmbH·1 device
Anti-K (KEL1) monoclonal, human IgM clone: MS-56
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·ANTITOXIN GmbH·1 device
Anti-AB monoclonal, IgM clones: ES-15, ES-4
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·ANTITOXIN GmbH·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
HSV-I/II IgM Antibody Detection Kit (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·DIRUI INDUSTRIAL CO., LTD·1 device
Anti-Dengue IgG/IgM Tri-line Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·1 device
VivaDiag Wellion IgM/IgG Rapid Test, lct, article number
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device