22 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Kind: Microbial Substances
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SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Basic UDI-DI
EU IVDR
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Eu Ivd Class D
·Jiangsu Medomics Medical Technology Co.,Ltd.·4 devices
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·1 device
HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·1 device
Access HBc IgM (Reagent Pack)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·1 device
Access Toxo IgM II
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
Access Rubella IgG
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
Access HBs Ab
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·1 device
Access HBs Ag Confirmatory
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·1 device
Access HBs Ag
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·1 device
Access CMV IgM
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
Access CMV IgG
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
Access Toxo IgG
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
Access Rubella IgM
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
FPSA-RIACT
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Cisbio Bioassays·1 device
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·1 device
Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·1 device
Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·1 device
Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR -Fluorescence Probing)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·1 device
Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·1 device
Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Daan Gene Co., Ltd.·1 device