emdn_classification MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER Manufacturer:

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eudamed_udi Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.

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eudamed_udi RevoDx HBV/HCV Qualitative qPCR Kit Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.

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eudamed_udi Truenat Dengue/Chikungunya Manufacturer: Molbio Diagnostics Limited

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eudamed_udi TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences

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eudamed_udi RIDA®Plex Viral 12 well Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi SARS-COV-2 Nucleocapsid(N) Antigen Rapid Detection kit (Colloidal gold method)) Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.

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eudamed_udi SARS-CoV-2 & Influenza A+B & RSV & ADV & Mycoplasma Pneumoniae Antigen Combo Test Kit (Colloidal Gold) Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi Tigsun Flu A/B, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi Diagnostic Kit for Zika /Dengue /Chikungunya virus RNA (Real-Time PCR Method) Manufacturer: Guangzhou Viuick Biotechnology Co.,LTD.

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eudamed_udi Duplex Real-Time PCR Detection Kit for Coxsackievirus A16 and Human Enterovirus 71 Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi Five Respiratory Pathogens Nucleic Acid Test Kit(PCR-Fluorescent Probe Method) Manufacturer: RocGene (Xuzhou) Technology Limited

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eudamed_udi Multi-Respiratory Antigen Test (Swab) Manufacturer: Aceso Laboratories, Inc.

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eudamed_udi FCFC-T502a Manufacturer: Healgen Scientific Limited Liability Company

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eudamed_udi Step 1 tubes for Herpes, Enterovirus and Adenovirus 8-well Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi Step 1 tubes for Viral 8-well Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi Rotavirus/Adenovirus Combo Test Manufacturer: Abiores Technology (Beijing) Co.,Ltd.

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eudamed_udi Fluxergy HVRe Influenza/RSV/ SARS-CoV-2 Manufacturer: Fluxergy Inc.

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eudamed_udi Influenza A / B / Parainfluenza virus Antigen Rapid Test Cassette (Colloidal Gold Method) Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.

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eudamed_udi Truenat Dengue/Chikungunya Manufacturer: Molbio Diagnostics Limited

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eudamed_udi SARS-CoV-2/InfluenzaA+B/RSV/Adenovirus/M. pneumoniae Antigen Combo Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA) Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi Tigsun Flu A/B, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab) Manufacturer: Healgen Scientific Limited Liability Company

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eudamed_udi COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA) Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.

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eudamed_udi Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Method) Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi Step 1 tubes for Viral Panel 12-well Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Coxsackievirus A16 and Human Enterovirus 71 Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi Adenovinus/RSV /influenza A+B Combo Rapid Test Cassette Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi Step 1 tubes for Viral CSF (8-well) Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi RIDA®Plex Viral and Syphilis 12 well Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi Multi-Respiratory Antigen test (Swab) Manufacturer: Aceso Laboratories, Inc.

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eudamed_udi SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.

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eudamed_udi SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay) Manufacturer: Shenzhen Microprofit Biotech Co., Ltd

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eudamed_udi Tigsun Flu A/B, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi TaqPath™ 1-Step Multiplex Master Mix (no ROX) Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences

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eudamed_udi RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.

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eudamed_udi Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi Adenovirus and RSV Combo Rapid Test Cassette Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.

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eudamed_udi Tigsun Flu A/B, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi Real-time PCR Detection Kit for Coxsackievirus A16, Enterovirus 71 and Enterovirus Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi Bosphore Viral Infections in the Immunosuppressed Panel Kit Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.

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eudamed_udi SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay) Manufacturer: Shenzhen Microprofit Biotech Co., Ltd

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eudamed_udi RSV/Influenza A+B Combo Rapid Test Cassette Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Bosphore Viral Infections in the Immunosuppressed Panel Kit Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.

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eudamed_udi Truenat Dengue/Chikungunya Manufacturer: Molbio Diagnostics Limited

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eudamed_udi TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences

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eudamed_udi Tigsun Flu A/B, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA) Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi Five Respiratory Virus Nucleic Acid Test Kit (PCR Fluorescent Probe Method) Manufacturer: RocGene (Xuzhou) Technology Limited

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eudamed_udi Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi Step 2 Plates for Viral CSF (8-well) Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Sansure Biotech Inc.

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eudamed_udi Influenza A/B Antigen Determination Kit (Fluorescence Immunochromatographic Assay) Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.

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eudamed_udi Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Method) Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences

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eudamed_udi Fluxergy HVRe Influenza/RSV/ SARS-CoV-2 Manufacturer: Fluxergy Inc.

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eudamed_udi SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi COVID-19 Antigen/Influenza A+B Combo Test Cassette Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Method) Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi Coxsackie virus group A type 16 & enterovirus type 71 Diagnostic Kit (PCR-Fluorescence Probing) Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd

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eudamed_udi SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.

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eudamed_udi Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi TaqPath™ COVID-19, Flu A/B, RSV Control Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences

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eudamed_udi Influenza A / B / Parainfluenza virus Antigen Rapid Test Cassette (Colloidal Gold Method) Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi COVID-19& Influenza A+B & RSV Antigen Combo Test Kit (LFA) Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi Flu A/RSV Ag Combo Rapid Test Cassette (Swab) Manufacturer: Healgen Scientific Limited Liability Company

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eudamed_udi Duplex Real-Time PCR Detection Kit for Coxsackievirus A16 and Human Enterovirus 71 Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi FCFLU(A/B)-502Fa Manufacturer: Healgen Scientific Limited Liability Company

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eudamed_udi Truenat Dengue/Chikungunya Manufacturer: Molbio Diagnostics Limited

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eudamed_udi Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Coxsackievirus A16 and Human Enterovirus 71 Manufacturer: Beijing Applied Biological Technologies Co., Ltd.

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eudamed_udi 2019-nCoV/Influenza A+B/RSV Antigen Combo Rapid Test Kit Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.

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eudamed_udi SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab) Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.

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eudamed_udi Five Respiratory Pathogens Nucleic Acid Test Kit(PCR-Fluorescent Probe Method) Manufacturer: RocGene (Xuzhou) Technology Limited

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eudamed_udi RIDA®Plex Viral 8 well Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi RSV/Influenza A+B Combo Rapid Test Cassette Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi Tigsun Flu A/B, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi COVID-19& Influenza A+B & RSV Antigen Combo Test Kit (LFA) Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi RIDA®Plex Viral 8 well Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi COVID-19& Influenza A+B & RSV Antigen Combo Test Kit (LFA) Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi RevoDx HBV/HCV Qualitative qPCR Kit Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.

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eudamed_udi SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.

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eudamed_udi Tigsun Flu A/B, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi Tigsun Flu A/B, COVID-19 Ag Combo Test Manufacturer: Beijing Tigsun Diagnostics Co., Ltd.

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eudamed_udi SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Bosphore Viral Infections in the Immunosuppressed Panel Kit Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.

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eudamed_udi TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences

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eudamed_udi Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Viral and Syphilis 12-well Manufacturer: AusDiagnostics Pty Ltd

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eudamed_udi RevoDx HBV/HCV Qualitative qPCR Kit Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.

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eudamed_udi FCRA-T502a Manufacturer: Healgen Scientific Limited Liability Company

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FDA Product Code: W0105070399