8,038 results
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45ms
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Sources: EU EUDAMED, US FDA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS
PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131
FDA registration
RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom
PSA Custom Control Levels 1, 2 and 3, IAC129, IAC130, IAC131
FDA registration
RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom
Kit, Igg, Platelet Associated
FDA classification
FDA Class 2
·Kit, Igg, Platelet Associated
Igg, Antigen, Antiserum, Control
FDA classification
FDA Class 2
·Igg, Antigen, Antiserum, Control
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
FDA classification
FDA Class 1
·Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Immunoglobulin G Kappa Heavy And Light Chain Combined
FDA classification
FDA Class 2
·Immunoglobulin G Kappa Heavy And Light Chain Combined
Immunoglobulin G (IgG) Detection Kit (Nephelometry)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Genrui Biotech Inc.·1 device
Immunoglobulin G (IgG) Detection Kit (Nephelometry)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Chikungunya IgG/IgM Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·1 device
IgG Konjugat/Conjugate (anti-human) LINE
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Gold Standard Diagnostics Frankfurt GmbH·3 devices
Dengue IgG/IgM Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·1 device
Tuberculosis IgG/IgM Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·1 device
Anti beta 2 Glycoprotein 1 IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Dia.Metra Srl·1 device
CHORUS EPSTEIN-BARR EARLY ANTIGEN IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·DIESSE Diagnostica Senese S.p.A·2 devices
BioCLIA Autoimmune Reagent Kit, RF IgG
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·HOB Biotech Group Corp., Ltd.·1 device
Dengue IgM/IgG Rapid Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Anbio (Xiamen) Biotechnology Co.,Ltd.·1 device
Lyme IgG/IgM Rapid Test Cassette
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Hangzhou Alltest Biotech.Co.,Ltd.·1 device
Anti Deamidated Gliadin Peptide (DGP) IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Dia.Metra Srl·1 device
Salmonella Typhi IgG/IgM Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device