Product Classification / EMDN Category
FDA Product Code: W0105900102
Directory of devices assigned to product classification code W0105900102.
emdn_classification
REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
Manufacturer:
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Vibrio Cholerae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Manufacturer: Sansure Biotech Inc.
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Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)
Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
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9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Manufacturer: Sansure Biotech Inc.
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Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for SARS-CoV-2
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Laborant Omicron VariAnt RT-qPCR Kit
Manufacturer: ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
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Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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Monkeypox Virus DNA Detection Kit (Real-Time PCR)
Manufacturer: Avioq Bio-tech Co., Ltd.
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Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing)
Manufacturer: Sansure Biotech Inc.
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Yersinia Pestis Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Schistosoma Haematobium Nucleic Acid Detection Kit（Fluorescent RAA)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Laborant SARS-CoV-2 RT-qPCR Kit
Manufacturer: ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ
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RAA Nucleic Acid Amplication Kit(Test Strip Method)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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VIASURE Viral Meningitis Panel Real Time PCR Detection Kit
Manufacturer: CERTEST BIOTEC S.L.
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RT-RAA Nucleic Acid Amplication Kit
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)
Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
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Monkeypox Virus Real Time PCR Kit
Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
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RT-RAA Nucleic Acid Amplication Kit
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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RAA Nucleic Acid Amplication Kit(Fluorescent Method)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)
Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
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Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）
Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
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Brucella Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）
Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
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Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)
Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
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Brucella Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Manufacturer: Sansure Biotech Inc.
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Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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VIASURE Viral Meningitis Panel Real Time PCR Detection Kit
Manufacturer: CERTEST BIOTEC S.L.
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Plasmodium Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Cell-Free Fetal DNA Library Prepare Kit
Manufacturer: Chengdu Find Medical Devices Co., Ltd.
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Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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Human Rhinovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Manufacturer: Sansure Biotech Inc.
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Schistosoma Mansoni Nucleic Acid Detection Kit（Fluorescent RAA)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Manufacturer: Sansure Biotech Inc.
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VIASURE Viral Meningitis Panel Real Time PCR Detection Kit
Manufacturer: CERTEST BIOTEC S.L.
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Salmonella Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Listeria Monocytogenes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Manufacturer: Sansure Biotech Inc.
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DENV/ZIKV/CHIKV/OROV/MAYV Fluorescence PCR Kit (Lyophilized)
Manufacturer: Healgen Scientific Limited Liability Company
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Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR)
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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MBGV/RVFV/CHIKV Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Manufacturer: Sansure Biotech Inc.
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Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR)
Manufacturer: BGI EUROPE A/S
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Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Schistosoma Haematobium Nucleic Acid Detection Kit（Fluorescent RAA)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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SARS-CoV-2 Variant B.1.617.2 Rapid Identification Kit (Fluorescence PCR)
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Yersinia Pestis Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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6 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Manufacturer: Sansure Biotech Inc.
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Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)
Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
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Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)
Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
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Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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RT-RAA Nucleic Acid Amplication Kit(Test Strip Method)
Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
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Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens
Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
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VIASURE Viral Meningitis Panel Real Time PCR Detection Kit
Manufacturer: CERTEST BIOTEC S.L.
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Sanity-2 Respiratory Pathogen Panel (RPP22)
Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
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miRNA Extraction Kit (magnetic bead method)
Manufacturer: Qingdao Anouve Biological Medical Technology Co. ,Ltd.
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Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)
Manufacturer: QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.
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i(17q) gene Probe Detection Kit (fluorescence in situ hybridization )
Manufacturer: Wuhan YZY Medical Science and Technology Co., Ltd
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