5,688 results
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45ms
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Sources: EU EUDAMED, US FDA
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Antibodies, Anti-Actin, Anti-Smooth Muscle
FDA classification
FDA Class 2
·Antibodies, Anti-Actin, Anti-Smooth Muscle
Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Ningbo BESTest Bio-technology Co.,Ltd.·1 device
Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Ningbo BESTest Bio-technology Co.,Ltd.·1 device
RV Rubella Antibodies IgM/IgG Rapid Test Kit(Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Qingdao Hightop Biotech Co., Ltd.·1 device
TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Qingdao Hightop Biotech Co., Ltd.·1 device
Anti-Dia, for card method Coombs-reactive, polyclonal, human IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANTITOXIN GmbH·1 device
Anti-Wra, for card method Coombs-reactive, polyclonal, human IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANTITOXIN GmbH·1 device
Anti-Cob, for card method Coombs-reactive, polyclonal, human IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANTITOXIN GmbH·1 device
Anti-Coa, for card method Coombs-reactive, polyclonal, human IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANTITOXIN GmbH·1 device
Anti-Lub, for card method Coombs-reactive, polyclonal, human IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANTITOXIN GmbH·1 device
Anti-Lua, for card method Coombs-reactive, polyclonal, human IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANTITOXIN GmbH·1 device
Anti-s, for card method Coombs-reactive, polyclonal, human IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANTITOXIN GmbH·1 device
Anti-S, for card method Coombs-reactive, polyclonal, human IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANTITOXIN GmbH·1 device
Anti-cellano, for card method monoclonal, human IgG clone: P3A1180L67
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANTITOXIN GmbH·1 device
Monkeypox Virus (MPV) IgG/IgM Antibody Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nantong EgensBiotechnology Co.,Ltd.·1 device
Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Ningbo BESTest Bio-technology Co.,Ltd.·1 device
Monkeypox Virus (MPXV) IgG/IgM Antibody Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Sciarray Biotech Co., Ltd.·1 device
ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·InTec PRODUCTS, INC.·1 device
Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·InTec PRODUCTS, INC.·1 device