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  • Clungene COVID-19 Antigen Rapid Test has obtained CE certification


    In February 2022, CLUNGENE® COVID-19 Antigen Rapid Test for self-testing manufactured by Clongene has obtained the CE certification in EU. Our self-testing product can be sold in the European Union and other countries that recognize the CE certification.

     

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    CLUNGENE® COVID-19 Antigen Rapid Test can be used by individuals for self-testing at home, and the result can be read at 15-20 minutes after the sample is added. Our product is convenient for individuals and families to detect nasal swab samples rapidly and timely.

     

    Product Features

    n  High specificity and sensitivity.

    n  Instant result at 15-20 minutes.

    n  Easy to collect samples.

    n  No equipment required.

    n  Results are clearly visible.

    n  Identify early infection.

     

    The CE certification of self-testing product in EU can better meet the requirements of people for self-testing and self-management at home, and further assist the global epidemic prevention and control.


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  • Clungene COVID-19 Antigen Rapid Test Products Obtained TGA Certification in Aust


    Clungene COVID-19 Antigen Rapid Test for self-testing” and “Clungene COVID-19 Antigen Rapid Test” manufactured by Clongene have obtained the TGA Certification in Australia on January 7, 2022. The certifications indicate that the Clungene COVID-19 Antigen Rapid Test products are approved to sold in the Australian market by the local government.

     

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    Australia is a well-known country with the strict management of drugs and higher requirements of market license. Therapeutic Goods Administration (TGA) is the federal drug regulatory agency under the Australian Department of Health. The products with the TGA certification are all evaluated by strict registration system in Australia.

     

    Clungene COVID-19 Antigen Rapid Test products are easy to use without the equipment, and can read visible results at 15-20 minutes. As a international-renowned brand for rapid test of COVID-19, Clungene COVID-19 Antigen Rapid Test products are effectively qualified to conduct the rapid detection in most markets around the world.

     

    Since the outbreak of the COVID-19, Clungene COVID-19 products have obtained the CE certification in EU, the TGA certification in Australia and some certifications from different countries, which demonstrate the quality of our products are approved by related government institutions. Also, our products have got good reputation from the main markets. Never stop moving forward! Clongene will keep to assist the prevention of the COVID-19 disease around the world and be an important force in the fight against the COVID-19.


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  • Surat Pernyataan Penghentian Kerjasama dengan PT. TAISHAN ALKES INDONESIA

    Surat Pernyataan Penghentian Kerjasama dengan PT. TAISHAN ALKES INDONESIA

    Dari: Hangzhou Clongene Biotech Co., Ltd.

    终止合作通告0517.pdf



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  • About infringement trademark and false statement

    Statement on PT. TAISHAN ALKES INDONESIA's infringement of  Clongene Biotech trademarks and forgery of false statements.

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  • About for Self-Testing


    We, Hangzhou Clongene Biotech Co., Ltd. as the manufacturer for Clungene COVID-19 Antigen Rapid Test(Self-Testing) declare that we never  has an exclusive distributor was authorized for German market.

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  • Good News! Clongene is on the Recognized List of Rapid Antigen Tests by the EU


    On 21 January 2021, Member States unanimously agreed on a Council recommendation setting a common framework for the use of rapid antigen tests and the mutual recognition of COVID-19 test results across the EU.

    The products need to meet the following requirements:

    (a) Carry CE marking;

    (b) Meet the minimum performance requirements of ≥ 90% sensitivity and ≥ 97% specificity; and

    (c) Have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies, such as the sample type used for validation, the setting in which the use of the test was assessed, and whether any difficulties occurred as regards the required sensitivity criteria or other performance elements.

    The Health Security Committee agrees that, for rapid antigen test results to be mutually recognized, at least three Member States should be using a rapid antigen tests in practice.


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    Clongene COVID-19 Antigen Rapid Test Kit with CE approved has become the main force of the anti-virus war in the EU, which also highlights the advantages of the product itself:

    l  easy to perform, but only for professional use.

    l  quick tests, enabling rapid implementation of infection control measures, including contact tracing.

    l  results are clearly visible.

    l  suitable for large-scale rapid screening.

    l  no equipment required.


    Above all, Clongene will keep moving and protecting the great health of human!




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  • CLUNGENE® COVID-19 Antigen Rapid Test Cassette Passed the PEI Test in Germany


    CLUNGENE®   COVID-19 Antigen Rapid Test Cassette has passed the test of PEI in Germany. PEI (Paul-Ehrlich-Institut) is affiliated to the Federal Ministry of Health. It is the Cooperation Centre of WHO for Quality Assurance of blood products and IVD equipment. The approval of PEI indicates the quality of the product has reachedthe international standard, and also indicates that our company has reached a new level in production technology, quality control, quality management and other aspects.


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  • CLUNGENE ® COVID-19 Antigen Rapid Test Cassette is approved in Switzerland


    We are glad to announce that Technical validation report CLUNGENE ® COVID-19 Antigen Rapid Test Cassette is received and the Test Kit has passed the validation criteria as described by the Swiss Society of Microbiology. It has been recommended by the Swiss authorities Bundesamt für Gesundheit as an antigen reagent for use outside the laboratory environment.


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  • MEDICAL FAIR INDIA 2020

    MEDICAL FAIR INDIA 2020


    March 5-7, 2020


    Bombay Exhibition Center Highway, Goreagon (East) - 400 063,India


    Clongene in 1C29


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  • Let's unite as one to fight the epidemic

    Hangzhou Clongene Biotech Co., Ltd is a hightech enterprise specialized in biological raw materials and in vitro diagnostic products. As well known biological raw materials supplier, which also specialized in producing products such as antigens, antibodies and enzymes, Clongene is facing the new coronavirus epidemic spreading situation. Clongene has a high degree of social responsibility, actively respond to the call of the party, fulfill the mission, developing rapidly to produce “The novel coronavirus antigen NCP” raw materials for all diagnostic test products.
    The antigen and antibody is available from now on!

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  • New arrival

         At the beginning of spring 2020, "Clongene" is introducing our latest developed biological raw material products. 

    For details, please contact: 

    manager Chen tel: +86 13506710950 & manager Wang tel: +86 15057189804

    new raw material product catalog 2020.2  .xls


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  • Medical Japan 2020

    Medical Japan 2020

    February 26-28, 2020

    1-5-102 Nanko-Kita, Suminoe-ku Osaka, 559-0034 Japan

    Clongene in Hall 6, number 3


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  • MEDLAB Middle East 2020

    Dubai International Exhibition Center, UAE

    February 3-6, 2020

    Clongene in Z2.B34


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  • Zdravookhraneniye-2019

    Expocentre Fairgrounds, Krasnopresnenskaya nab., 14
    Moscow, Russia, 123100  2-6 Dec


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  • MEDICA 2019, November 18th - 21st, at Dusseldorf in Germany

    We sincerely invite you and your company to visit our booth H3J92-9 for MEDICA 2019, November 18th - 21st, at Dusseldorf in Germany.

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  • CMEF2019 QINGDAO

    We sincerely invite you and your company to visit our booth S3-K11 for the 82nd China International Medical Equipment Fair (CMEF Autumn 2019), October 19th - 22nd, at Qingdao World Expo City (Qingdao).

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  • HOSPITAL EXPO 2019

    We sincerely invite you and your company to visit our booth HB131 for the 2019 Indonesia Hospital Expo, October 23rd - 26th, at the Jakarta Convention Center in Jakarta, Indonesia.

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