Shenzhen Reagent Technology Co., Ltd.
China Last updated 21 Oct 2026
- Devices
- 18
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Sickle Cell Screen Rapid Test Ref RNPT95001-01
Ebola Virus Antigen Rapid Test Kit Ref RNPT96029-01
Eleven Respiratory Pathogens Antigen Rapid Test Kit (NPS) Ref RNPT98811-20
Ebola Virus Antigen Rapid Test Kit Ref RNPT96029-20
Hantavirus Antigen Rapid Test Kit Ref RNPT96028-01
HPV 16/18 E7 Antigen Rapid Test Kit Ref RNS92306-01
Measles IgG/lgM Rapid Test Kit Ref RNPT96011-01
Hantavirus IgG/IgM Antibody Rapid Test Kit Ref RNPT96027-20
Hantavirus IgG/IgM Antibody Rapid Test Kit Ref RNPT96027-01
COVID-19 & Influenza A/B Antigen Combo Test Kit Ref RNS92048C
Nine Respiratory Pathogens Antigen Rapid Test Kit Ref RNS92190
SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit Ref RNS92146
Eleven Respiratory Pathogens Antigen Rapid Test Kit Ref RNS92111
Nine Respiratory Pathogens Antigen Rapid Test Kit Ref RNS92190
TriClear CA/TV /GV Antigen Combo Rapid Test Kit Ref RNS92331
Twelve Respiratory Pathogens Antigen Rapid Test Kit Ref RNS92343
SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit Ref RNS92131
Ten Respiratory Pathogens Antigen Rapid Test Kit Ref RNS92110
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Authorised representatives
What Shenzhen Reagent Technology Co., Ltd. makes
The company manufactures rapid diagnostic test kits designed for point-of-care use, including antigen and antibody tests for infectious diseases. These products detect markers for hantavirus, COVID-19, influenza, respiratory syncytial virus (RSV), adenovirus, and other respiratory pathogens. The kits are intended for clinical or home testing to identify current or past infections. Some variants combine multiple pathogens into a single test for broader screening purposes.
The portfolio falls under the In Vitro Diagnostic Medical Device (IVD) General classification, with devices registered in the EUDAMED database. The company is based in China and adheres to relevant regulatory frameworks for diagnostic testing in international markets.
Frequently asked questions
How many devices does Shenzhen Reagent Technology Co., Ltd. have in the registry?
The registry currently lists 18 devices for Shenzhen Reagent Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Reagent Technology Co., Ltd.'s devices?
Among its 18 most recently registered devices, Shenzhen Reagent Technology Co., Ltd. has devices listed in EUDAMED (18 devices).
What risk classes do Shenzhen Reagent Technology Co., Ltd.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Shenzhen Reagent Technology Co., Ltd.'s devices are IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Reagent Technology Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Reagent Technology Co., Ltd. include Sickle Cell Screen Rapid Test, Ebola Virus Antigen Rapid Test Kit, Eleven Respiratory Pathogens Antigen Rapid Test Kit (NPS) and Hantavirus Antigen Rapid Test Kit.
Information
- Address
- Room 1601, Building No.3, YESUN INTELLIGENT COMMUNITY I, No.1301-77, Guanguang Road, Shenzhen, China
- Website
- www.reagen.us
- [email protected]
- Phone
- +1 619-3898888
- PRRC contact
- Zeng Xiangfu
- EUDAMED SRN
- CN-MF-000047757