8,038 results
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59ms
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Sources: EU EUDAMED, US FDA
Labmaster LUCIA™ SARS-CoV-2 IgG RBD Kit for Whole Blood Samples
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Labmaster Oy·1 device
Labmaster LUCIA™ SARS-CoV-2 IgG NP Kit for Whole Blood Samples
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Labmaster Oy·1 device
Eurolink Europe Compliance Limited
Authorized representative
🇮🇪 Ireland·35 Manufacturers·252 Devices
Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 1Vial/carton Box
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Atlas Medical GmbH·1 device
Diagnostic Station DS20
FDA UDI
Schiller AG·07613365000498·The Diagnostic Station DS20 is a 12-lead ECG de...
Diagnostic Station DS20
FDA UDI
Schiller AG·07613365000467·The Diagnostic Station DS20 is a 3-lead ECG dev...
Diagnostic Station DS20
FDA UDI
Schiller AG·07613365000481·The Diagnostic Station DS20 is a 3-lead ECG dev...
Diagnostic Station DS20
FDA UDI
Schiller AG·07613365000474·The Diagnostic Station DS20 is a 12-lead ECG de...
Vingmed Oy
Importer
🇫🇮 Finland·7 Manufacturers
Anti-CDE monoclonal, human IgM + IgG clones: MS-24, MS-201, MS-80, MS-26
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·ANTITOXIN GmbH·1 device
Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 10 vials/Plastic Pack
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Atlas Medical GmbH·1 device
Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 10 vials/Plastic Pack
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Atlas Medical GmbH·1 device
Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 1 vial/carton Box
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Atlas Medical GmbH·1 device
Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgM/IgG Antibody (Colloidal Gold Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhongshan Bio-Tech Co., Ltd.·1 device
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
FDA classification
FDA Class 2
·Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
FDA classification
FDA Class 2
·Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device