114 results
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8ms
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Sources: EU EUDAMED, US FDA
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Kind: Professional Testing
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NeoMass CAH Multilevel Calibrators, Dried Blood Spot Calibrators Level 0-7
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Labsystems Diagnostics Oy·1 device
Freeze-dried Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device
CONTROL POSITIVO EN SECO ROTA-ADENO-NORO/DRY POSITIVE CONTROL ROTA-ADENO-NORO
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·OPERON, S.A.·1 device
Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device
Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device
Freeze-dried 14 Types of Human Papillomavirus Nucleic Acid Typing Detection Kit (Fluorescence PCR)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device
Respiratory 7 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method; Freeze-dried)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Suzhou TianLong Biotechnology Co., Ltd.·1 device
Respiratory 17 Types Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescence PCR Method; Freeze-dried)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Suzhou TianLong Biotechnology Co., Ltd.·1 device
ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·RECIPE Chemicals + Instruments GmbH·1 device
Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device
Lactate dehydrogenase，α-hydroxybutyrate dehydrogenase，creatine kinase，creatine kinase MB test card (dry chemical method)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.·1 device
Lactate dehydrogenase，α-hydroxybutyrate dehydrogenase，creatine kinase，creatine kinase MB test card (dry chemical method)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.·1 device
Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device
Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)-Subpackage
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device