1Product IntroductionCOVID-19 IgG/IgM Rapid Test COVID-19 Antigen Rapid Test Kit

Intend Use

GenSureTM COVID-19 IgG/IgM Rapid Test is used for the qualitative testing of novel coronavirus IgM and IgG antibodies in human serum, plasma or whole blood in vitro, and can be used for clinical auxiliary diagnosis of novel coronavirus infection.

The GenSureTM COVID-19 Antigen Rapid Test Kit is intended for the qualitative detection of the N protein antigen from novel coronavirus in human nasal swab specimens directly. Testing is limited to laboratories and medical institutions.

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GenSureTM COVID-19 IgG/IgM Rapid Test REF: P2002QTY/Package 20 PCS

Net Weight/Package 0.21 KG

Gross Weight/Package 0.25 KG

Size/Package 17*14*6 CM

QTY/Carton 30PK/Carton,600PCS/Carton

Net Weight/Carton 7.6 KG

Gross Weight/Carton 8.5 KG

Size/Carton 42.9*34.8*30.5 CM

GenSureTM COVID-19 Antigen Rapid Test Kit REF: P2004QTY/Package 20 PCS

Net Weight/Package 0.23 KG

Gross Weight/Package 0.27 KG

Size/Package 18*15*6.5 CM

QTY/Carton 30PK/Carton,600PCS/Carton

Net Weight/Carton 8.1 KG

Gross Weight/Carton 9.2 KG

Size/Carton 46.5*37.5*34 CM

Test Principle

The microsphere immunochromatographic technology was used to detect the novel coronavirus (2019-nCoV) IgG/IgM antibody in human serum / plasma / whole blood with the principle of capture method.

The polymer immunochromatographic technology and double antibody sandwich principle were used to detect the novel coronavirus antigen in human nasal swab specimens with the principle of capture method.

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CE CERTIFICATE

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ISO 13485 CERTIFICATE

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https://www.finddx.org/cov id-19/pipeline/

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Test Report

DGM

Company Profile

2 GenSure Biotech Inc.,

GenSure Biotech Inc., was established in 2016 and is located in Shijiazhuang Economic and Technological Development Zone. GenSure's DFCTM near-infrared fluorescence quantitative detection platform with independent intellectual property rights can realize one-step operation, intelligent identification, rapid acquisition of test results within 15 minutes, and compatibility with the detection of more than 60 immune markers, not only suitable for the rapid diagnosis of critical illnesses at the bedside in large and medium-sized hospital, but also suitable for the quantitative analysis of immunological tests in the laboratory of small and medium-sized hospitals. It is also suitable for the needs of primary hospitals to realize the detection of common diseases. By the beginning of 2020, the company has obtained 23 NMPA certified medical device certificates, and has become one of the enterprises with the most complete POCT product line in China.

Company Profile

Business License and Medical Device Production License

Remittance route of China Construction Bank

Bank Name: China construction bank head office Beijing

Address: No.9 Changjiang Road, Shijiazhuang 050000, P.R China

Tel: 86-311-8538 9600

Beneficiary: Hebei GenSure Biotech Inc.,

A/C NO.13050161200800000657

Swift Code : PCBCCNBJ

USD Account：13050161200800001630

Euro Account：13050161200800001631

HKD Account：13050161200800001632

Contact Us

Tel: 0086-0311-89937995 0086-0311-89937996

Fax：0086-0311-89937997

Add: 3/F, Block 1, Boyun Building, No. 9 Fengchan Rd, Economic-Tech

Development Zone, Shijiazhuang, 050000, Hebei, P.R China.