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Respiratory Infectious Diseases IVD Products

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COVID-19 SOLUTIONs

COVID-19 IgG/IgM Rapid Test P2002

COVID-19 IgG/IgM Rapid Test P2004

GenSure™ COVID-19 Antigen Rapid Test Kit P2004s

COVID-19 Neutralizing Antibody Test(Fluorescence) P2005

COVID-19 Neutralizing Antibody Test(Latex) P2006

COVID-19/Flu A+B Antigen Combo Rapid Test P2007

SARS-CoV-2 N / S IgG Combo Rapid Test P2010

Monkeypox Virus Solutions

GenSure™ Monkeypox Virus(MPXV) IgM/IgG Antibody Rapid Test P2044

GenSure™ Monkeypox Virus(MPXV) Antigen Rapid Test P2046

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COVID-19 IgG/IgM Rapid Test P2004

The GenSure™ COVID-19 Antigen Rapid Test Kit is a rapid direct binding test for the visual detection of SARS-CoV-2 antigen in human nasal swab specimens as an aid in the diagnosis of SARS-CoV-2 infection.

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Product Specification

Product Name	GenSure™ COVID-19 Antigen Rapid Test Kit	Results Reading Time	10-15 minutes
REF	P2004	Instrument	No
Intended Use	SARS-CoV-2 Antigen	Storage Temperature	4-30°C
Specimen type	nasal	Shelf Life	18 months
Pack	1 pack　2 pack　5 pack　20 pack	Certificate	CE

Instruction Video

COVID-19 IgG/IgM Rapid Test P2002

GenSure™ COVID-19 Antigen Rapid Test Kit P2004s

IFU

IFU_REF P2004_GenSure COVID-19 Antigen Rapid Test Kit.pdf

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2022-11-21 16:34:20

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COVID-19 IgG/IgM Rapid Test P2002

This product is used for the qualitative testing of novel coronavirus (2019-nCoV) IgM and IgG antibodies in human serum, plasma or whole blood in vitro, and can be used for clinical auxiliary diagnosis of novel coronavirus (2019-nCoV) infection. The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

COVID-19 IgG/IgM Rapid Test P2004

GenSure™ COVID-19 Antigen Rapid Test Kit P2004s

The GenSure™ COVID-19 Antigen Rapid Test Kit is a polymer immunochromatographic technology and double antibody sandwich principle that is intended for the qualitative detection of the N protein antigen from SARS-CoV-2 in human nasal swab specimens directly. Testing is limited to laboratories and medical institutions.

COVID-19 Neutralizing Antibody Test(Fluorescence) P2005

The GenSure™ COVID-19 19 Neutralizing Antibody Test (Fluorescence) is for in vitro qualitative detection of the neutralizing antibodies against SARS-CoV-2 in human serum, plasma or whole blood.

COVID-19 Neutralizing Antibody Test(Latex) P2006

The GenSure™ COVID-19 Neutralizing Antibody Rapid Test (Latex) is a lateral flow assay intended for the qualitative detection of RBD antibody to SARS-CoV-2 in human serum, plasma or whole blood in vitro.

COVID-19/Flu A+B Antigen Combo Rapid Test P2007

The COVID-19/Flu A/B Antigen Combo Rapid Test is an in vitro rapid diagnostic immunochromatographic assay intended for the simultaneous qualitative detection and differentiation of the antigens from novel coronavirus, influenza A and influenza B in direct nasal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to novel coronavirus and influenza can be similar. It is not intended to detect influenza C.

SARS-CoV-2 N / S IgG Combo Rapid Test P2010

The SARS-CoV-2 N / S IgG Combo Rapid Test is used for the qualitative testing of SARS-CoV-2 IgG antibody to nucleocapsid (N) and spike (S) protein in human serum, plasma or whole blood in vitro. It is used to assist in the diagnosis of SARS-CoV-2 infection and to detect whether the SARS-CoV-2 IgG antibody to N / S protein is generated in the blood after injected with the vaccine.

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