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Jiangsu Qitian Gene biotechnology Co., Ltd

China·CN-MF-000050877

Last updated September 18, 2026

About

THE JIANGSU QI TIAN GENE FOCUSES ON THE DEVELOPMENT AND APPLICATION OF THERMONUCLEIC ACID ENRICHMENT TECHNIQUES SUCH AS REASSEMBLY ENZYME GUIDANCE (ARA TECHNOLOGY)。

Translated from the manufacturer's own website. Source

What Jiangsu Qitian Gene biotechnology Co., Ltd makes

The company produces nucleic acid detection kits designed for identifying specific viral and bacterial pathogens through isothermal amplification and fluorescent reverse transcription recombinase amplification (RT-RAA) methods. These include kits for Ebola, SARS-CoV-2, dengue virus, Brucella, mpox virus, *Enterobacter sakazakii*, *Staphylococcus aureus*, and COVID-19, enabling rapid diagnostic testing in clinical and research settings.

The portfolio consists of in vitro diagnostic (IVD) devices classified as Class A under EU regulations, with some listed in the EUDAQD (eudamed) database. The company operates from China, adhering to relevant regulatory frameworks for nucleic acid-based diagnostic tools.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: China
Address: 97-1, Linghu Avenue, Wuxi, Jiangsu, China
Website: www.qt-bio.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 0510 85385531
PRRC Contact: Shengbing Su
EUDAMED SRN: CN-MF-000050877
FDA FEI Number: —
DUNS Number: —

Catalogue (55)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)	F03R21A-48	EUDAMED	IVD General	Active
SARS-CoV-2 Nucleic Acid Detection Kit	/	EUDAMED	IVD General	Active
Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）	F03R10AⅢ-96	EUDAMED	IVD General	Active
Brucella Nucleic Acid Detection Kit（Isothermal Amplification)	F01008A-24	EUDAMED	IVD General	Active
Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)	F03006A-48	EUDAMED	IVD General	Active
RT-RAA Nucleic Acid Amplication Kit	B00R00A	EUDAMED	Class A	Active
Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）	F03R10AⅢ-24	EUDAMED	IVD General	Active
Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)	F01003A-96	EUDAMED	IVD General	Active
RAA Nucleic Acid Amplication Kit(Fluorescent Method)	F00001A-96	EUDAMED	Class A	Active
COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)	F02R13AIV-96	EUDAMED	IVD General	Active
Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)	F01002A-96	EUDAMED	IVD General	Active
Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)	F03006A-24	EUDAMED	IVD General	Active
Yersinia Pestis Nucleic Acid Detection Kit（Isothermal Amplification)	F03019A-96	EUDAMED	IVD General	Active
Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)	F01004A-96	EUDAMED	IVD General	Active
Schistosoma Mansoni Nucleic Acid Detection Kit（Fluorescent RAA)	F06005A-96	EUDAMED	IVD General	Active
RAA Nucleic Acid Amplication Kit	B00000A-96	EUDAMED	Class A	Active
Yersinia Pestis Nucleic Acid Detection Kit（Isothermal Amplification)	F03019A-24	EUDAMED	IVD General	Active
Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)	F03020A-96	EUDAMED	IVD General	Active
Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)	F03R21A-96	EUDAMED	IVD General	Active
Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification)	F03R12A-24	EUDAMED	IVD General	Active
Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification)	F03R01A-96	EUDAMED	IVD General	Active
RAA Nucleic Acid Amplication Kit(Test Strip Method)	T00001A	EUDAMED	Class A	Active
Zika Virus Nucleic Acid Detection Kit（Isothermal Amplification)	F03R05A-96	EUDAMED	IVD General	Active
Nucleic Acid Extraction Reagent	LZD002-64Y	EUDAMED	Class A	Active
Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)	F01009A-96	EUDAMED	IVD General	Active
Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification)	F03R12A-48	EUDAMED	IVD General	Active
RT-RAA Nucleic Acid Amplication Kit	B00R00A-96	EUDAMED	Class A	Active
Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)	F01009A-24	EUDAMED	IVD General	Active
Nucleic Acid Extraction Reagent	LZD001-64JⅠ	EUDAMED	Class A	Active
Schistosoma Haematobium Nucleic Acid Detection Kit（Fluorescent RAA)	F06004A-24	EUDAMED	IVD General	Active
Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)	F01009A-48	EUDAMED	IVD General	Active
RAA Nucleic Acid Amplication Kit(Fluorescent Method)	F00001A	EUDAMED	Class A	Active
Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)	F03006A-96	EUDAMED	IVD General	Active
Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)	F01003A-48	EUDAMED	IVD General	Active
RT-RAA Nucleic Acid Amplication Kit(Test Strip Method)	T00R01A-96	EUDAMED	Class A	Active
COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)	F02R13AIV-24	EUDAMED	IVD General	Active
Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)	F01004A-48	EUDAMED	IVD General	Active
Nucleic Acid Extraction Reagent	LZD001-32JII	EUDAMED	Class A	Active
Brucella Nucleic Acid Detection Kit（Isothermal Amplification)	F01008A-96	EUDAMED	IVD General	Active
RT-RAA Nucleic Acid Amplication Kit(Fluorescent Method)	F00R01A-96	EUDAMED	Class A	Active
Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)	F03020A-24	EUDAMED	IVD General	Active
Salmonella Nucleic Acid Detection Kit（Isothermal Amplification)	F01001A-48	EUDAMED	IVD General	Active
Listeria Monocytogenes Nucleic Acid Detection Kit（Isothermal Amplification)	F01006A-96	EUDAMED	IVD General	Active
Plasmodium Nucleic Acid Detection Kit（Isothermal Amplification)	F03014A-96	EUDAMED	IVD General	Active
Schistosoma Mansoni Nucleic Acid Detection Kit（Fluorescent RAA)	F06005A-24	EUDAMED	IVD General	Active
Nucleic Acid Extraction Reagent	LZD002-32Y	EUDAMED	Class A	Active
Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification)	F03R01A-24	EUDAMED	IVD General	Active
Nucleic Acid Extraction Reagent	LZD001-64YⅠ	EUDAMED	Class A	Active
Plasmodium Nucleic Acid Detection Kit（Isothermal Amplification)	F03014A-24	EUDAMED	IVD General	Active
Nucleic Acid Extraction Reagent	LZD002-32J	EUDAMED	Class A	Active

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