emdn_classification VIROLOGY - RT & POC - OTHER Manufacturer:

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eudamed_udi SARS-CoV-2/M.pneumoniae IgG/IgM Combo Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi CerTest Rotavirus+Adenovirus+Astrovirus Manufacturer: CERTEST BIOTEC S.L.

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eudamed_udi Adenovirus Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Capilia Strep A 20T/Box Manufacturer: TAUNS Laboratories, Inc.

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eudamed_udi SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method) Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd

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eudamed_udi Simple Rota-Adeno-Noro Manufacturer: OPERON, S.A.

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eudamed_udi COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit Manufacturer: Sejoy Biomedical Co., Ltd.

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eudamed_udi CerTest Rotavirus+Adenovirus+Astrovirus Manufacturer: CERTEST BIOTEC S.L.

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eudamed_udi Chikungunya IgG/IgM Rapid Test(Whole Blood/Serum/Plasma) Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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eudamed_udi SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

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eudamed_udi Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal Swab) Manufacturer: Salofa Oy

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eudamed_udi InfluenzaA+B&COVID-19 (SARS-CoV-2)Antigen Test Kit（Colloidal Gold） Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing) Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.

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eudamed_udi CerTest Astrovirus Manufacturer: CERTEST BIOTEC S.L.

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eudamed_udi VID206 Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi 2019-nCoV Neutralizing Antibody Detection Kit (Fluorescence Immunochromatography) Manufacturer: Shenzhen Superbio Technology Co.,Ltd.

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eudamed_udi COVID-19 Antigen Rapid Test Cassette (Colloidal Gold ) Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.

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eudamed_udi Zika IgM/IgG Rapid Test(Serum/Plasma) Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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eudamed_udi CerTest Astrovirus Manufacturer: CERTEST BIOTEC S.L.

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eudamed_udi FLU A&B &COVID-19 & RSV & Adeno Antigen Combo Test Cassette Manufacturer: Jiangsu Mole Bioscience Co., LTD.

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eudamed_udi Rapid COVID-19 Antigen Self-Test Manufacturer: Healgen Scientific Limited Liability Company

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eudamed_udi SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal gold method) Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

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eudamed_udi Monkeypox Virus Real Time PCR Kit Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.

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eudamed_udi Adenovirus/RSV Combo Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi POC SARS-CoV-2 Nucleic Acid Detection Kit Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.

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eudamed_udi COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd

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eudamed_udi Simple Rotavirus / Stick Rotavirus Manufacturer: OPERON, S.A.

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eudamed_udi biotical Norovirus Gen I + II Card Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold) Manufacturer: Shenzhen Superbio Technology Co.,Ltd.

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eudamed_udi HSV 1/2 IgG/IgM Rapid Test Manufacturer: Hangzhou Clongene Biotech Co., Ltd.

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eudamed_udi biotical Norovirus Gen I + II Card (+PC +NC) Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi Adenovirus Antigen Rapid Test (Feces) Manufacturer: Hangzhou Clongene Biotech Co., Ltd.

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eudamed_udi Clarity COVID-19 Antigen Rapid Test Cassette Manufacturer: Salofa Oy

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

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eudamed_udi Rotavirus Rapid Test Manufacturer: Acro Biotech Inc.

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eudamed_udi COVID-19 Neutralization Ab+ Rapid Test Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

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eudamed_udi Chikungunya Test Device(Serum/plasma/whole blood) Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.

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eudamed_udi COVID-19 IgG/IgM Rapid Test Device Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

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eudamed_udi COVID-19 Antigen Nasal Test Kit Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.

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eudamed_udi Norovirus Rapid Test Manufacturer: Acro Biotech Inc.

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eudamed_udi COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd

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eudamed_udi 2019-nCoV Antigen Test (Lateral Flow Method) Manufacturer: Zhongshan Bio-Tech Co., Ltd.

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eudamed_udi HSV IgG/IgM Rapid Test Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.

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eudamed_udi Rotavirus Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) Manufacturer: Zhongshan Bio-Tech Co., Ltd.

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eudamed_udi H.pylori Antigen Rapid Test Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

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eudamed_udi Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.

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eudamed_udi HSV Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi EV71 IgM Rapid Test Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.

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eudamed_udi Chikungunya IgG/IgM Combo Rapid Test Kit (Colloidal Gold) Manufacturer: BIOBASE POCT CO.,LTD

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eudamed_udi Rapid SARS-CoV-2 Antigen Test Card Manufacturer: BioDetect（Xiamen）Biotechnology Co., Ltd.

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eudamed_udi Hantavirus IgG/IgM Rapid Test(WB/S/P) Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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eudamed_udi SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi Chikungunya IgG/IgM Rapid Test Manufacturer: Hangzhou Clongene Biotech Co., Ltd.

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eudamed_udi Zika Test Device (Serum/plasma/whole blood) Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.

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eudamed_udi COVID-19 nucleic acid Test kit (fluorescence PCR) Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

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eudamed_udi Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab) Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd

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eudamed_udi COVID-19 Ab Test Kit（ELISA） Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

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eudamed_udi Respiratory Multiple Rapid Test Kit (Immunochromatography) Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.

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eudamed_udi Capilia hMPV Test Plate 10T/Box Manufacturer: TAUNS Laboratories, Inc.

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eudamed_udi Chikungunya IgG/IgM Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi CerTest Rotavirus+Adenovirus Manufacturer: CERTEST BIOTEC S.L.

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eudamed_udi InfluenzaA+B&COVID-19 (SARS-CoV-2)Antigen Test Kit（Colloidal Gold） Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi Rapid Adenovirus Antigen Test Card Manufacturer: Xiamen Boson Biotech Co., Ltd.

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eudamed_udi Influenza A/B virus Antigen Rapid Test Kit Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.

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eudamed_udi Dispositivo de Prueba Rápida para Chikungunya IgG/IgM Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA) Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.

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eudamed_udi COVID-19 Antigen Detection Kit-Nasal swab Manufacturer: New Gene (Hangzhou) Bioengineering Co., Ltd.

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eudamed_udi FLU A/B & SARS-Cov-2 & RSV& ADV &PIV I/III &PIV II &MP & HMV & HRV Combo Rapid Test Device Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd

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eudamed_udi biotical Rotavirus + Adenovirus Card Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi CerTest Norovirus Manufacturer: CERTEST BIOTEC S.L.

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eudamed_udi COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

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eudamed_udi INDICAID™ Chikungunya Rapid Antibody Test Manufacturer: Phase Scientific International Limited

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eudamed_udi COVID-19 Antigen Saliva Test Kit Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.

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eudamed_udi HAV IgM Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi COVID-19 Ag Test Kit Manufacturer: Guangdong Wesail Biotech Co., Ltd.

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eudamed_udi Syphilis Rapid Test Kit (Colloidal Gold Method) Manufacturer: FARMASINO MEDICAL CO., LTD

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eudamed_udi SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi FluCov2 Manufacturer: DYONMED SA

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eudamed_udi Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold) Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.

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eudamed_udi COVID-19 Neutralizing Antibodies Rapid Test Kit (Colloidal Gold) Manufacturer: Jiangsu Accuracy Biotechnology Co.,Ltd.

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eudamed_udi Strep. pneumoniae Antigen Rapid Test Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

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eudamed_udi CerTest Rotavirus Manufacturer: CERTEST BIOTEC S.L.

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eudamed_udi COVID-19 Antigen FIA Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.

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eudamed_udi Zika Antigen Assay Kit(Colloidal gold) Manufacturer: Avioq Bio-tech Co., Ltd.

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eudamed_udi COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test Manufacturer: Hangzhou Clongene Biotech Co., Ltd.

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eudamed_udi biotical Rotavirus Card Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi Influenza A+B/COVID-19 Antigen Combined Rapid Test Kit (Colloidal Gold Method) Manufacturer: FARMASINO MEDICAL CO., LTD

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eudamed_udi Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA) Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.

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eudamed_udi SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit(Fluorescence Immunoassay) Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd

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eudamed_udi Aidian LF SARS-CoV-2 Ag Test Manufacturer: Aidian Oy

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eudamed_udi Adenovirus/RSV/Influenza A+B Combo Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold method) Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

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eudamed_udi COVID-19 Antigen Rapid Test Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.

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eudamed_udi COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) Manufacturer: Zhongshan Bio-Tech Co., Ltd.

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eudamed_udi HPIV Antigen Rapid Test (Immunochromatographic Assay) Manufacturer: Shenzhen Superbio Technology Co.,Ltd.

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eudamed_udi CerTest Rotavirus+Adenovirus Manufacturer: CERTEST BIOTEC S.L.

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eudamed_udi CerTest Influenza A+B+RSV Manufacturer: CERTEST BIOTEC S.L.

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FDA Product Code: W0105099099