REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS

EMDN W0105900102

Registry term list. Not a clinical opinion. 228 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
6 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	06955792734913	Sansure Biotech Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
6 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	06955792734920	Sansure Biotech Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	06955792734890	Sansure Biotech Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	06955792734906	Sansure Biotech Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Anouve	06975978080047	Qingdao Anouve Biological Medical Technology Co. ,Ltd.	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Anouve	06975978080054	Qingdao Anouve Biological Medical Technology Co. ,Ltd.	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Anouve	06975978080061	Qingdao Anouve Biological Medical Technology Co. ,Ltd.	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ATM/p53/13q14/RB1/CSP12 gene Probe Detection Kit (fluorescence in situ hybridization )	06974604726182	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440600	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440617	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440624	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Bactfast	04793002939008	Credence Genomics Pvt. Ltd.	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	06955792734050	Sansure Biotech Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	06955792734067	Sansure Biotech Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Brucella Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440815	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Brucella Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440822	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Brucella Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440839	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Cell-Free Fetal DNA Library Prepare Kit	06975532360028	Chengdu Find Medical Devices Co., Ltd.	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ChainFor™	08684595034767	Vitrosens Biotechnology Inc.	Class C	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ChainFor™	08684595034774	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
ChainFor™	08684595034781	Vitrosens Biotechnology Inc.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440877	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440884	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440891	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Coxsackievirus A10 Real Time RT-PCR Kit	06971042225918	SHANGHAI ZJ BIO-TECH CO., LTD	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Coxsackievirus A6 Real Time RT-PCR Kit	06971042225888	SHANGHAI ZJ BIO-TECH CO., LTD	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Demi DNA Reagent Cassette	09343044003073	AusDiagnostics Pty Ltd	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Demi RNA Reagent Cassette	09343044003110	AusDiagnostics Pty Ltd	Class A	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）	06975102441058	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）	06975102441065	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）	06975102441072	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	06971760720016	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	06971760720023	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	06971760720030	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	06971760720047	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	06971760720054	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	16971760720013	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	16971760720020	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	16971760720037	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	16971760720044	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)	16971760720051	QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)	06973492240299	Ustar Biotechnologies (Hangzhou) Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440631	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440648	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440655	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440723	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440730	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)	06975102440747	Jiangsu Qitian Gene biotechnology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Eye Infection Detection and Monitoring Kit (24)	08684190150237	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED
Eye Infection Detection and Monitoring Kit (24)	08684190152293	ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI	Unknown class	No Certificate Found Snapshot 2026-10-10 · Link to EUDAMED