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    BfArM PEI Listed CE Marked SARS-CoV-2 Antigen Test Kit

    Germany BfArM PEI Listed CE Marked COVID-19 Antigen Rapid Test Kit. Clinical specificity: 100%, Clinical sensitivity: 97.17%
    • Goldsite

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    Germany BfArM PEI Listed

    CE Notified Body Certificate 

    COVID-19  SARS-CoV-2 Antigen Kit for both Self-testing (zur Eigenanwendung) and Professional Use English Deutsch bilingual packaging





    Polish Centre for Testing and Certification



    微信图片_20211129105940

    德语包装

    SARS-CoV-2 Antigen Test is used for detection of proteins from the virus that causes COVID-19. A positive result indicates the presence of viral antigens, implying current viral infection. Like RT-PCR test, the antigen test also detects the virus directly, and performs best when the person is tested in the early stages of infection with SARS-CoV-2. The antigen test is very specific, indicating that a positive result is highly accurate. Compared with RT-PCR test, the antigen test is much easier, affordable, and faster. 

    In addition, the antigen test can be performed at the point-of-care without the requirements for highly complex instruments and expertise.



    Antigen

    FEATURES

    • EASY. No special equipment and expertise needed.

    • RAPID. Only 12 mins waiting time.

    • Nasal swab

    • Good correlation with RT-PCR detection.

    • Room temperature storage

    • Over the counter (OTC) accessible in Germany and Europe. both for professional use and self testing.

    • Bfarm Listed in Germany

    • Passed PEI evaluation


    What is PEI 

    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.

    Cat.No

    Description

    Package size

    CG123001

    SARS-CoV-2 Antigen Kit (Colloidal Gold) for professional use

    1T

    CG123005

    SARS-CoV-2 Antigen Kit (Colloidal Gold) for professional use

    5T

    CG123025SARS-CoV-2 Antigen Kit (Colloidal Gold) for professional use25T


    Cat.No

    Description

    Package size

    CG123001

    SARS-CoV-2 Antigen Kit (Colloidal Gold) for Self-testing

    1T

    CG123003SARS-CoV-2 Antigen Kit (Colloidal Gold) for Self-testing3T

    CG123005

    SARS-CoV-2 Antigen Kit (Colloidal Gold) for Self-testing

    5T

    CG123007SARS-CoV-2 Antigen Kit (Colloidal Gold) for Self-testing7T
    CG123025SARS-CoV-2 Antigen Kit (Colloidal Gold) for Self-testing25T


    Sample type

    Nasal Swab/ nasopharyngeal swab

    Kit components

    List

    Size/volume/quantity

    Test cartridge

    1/3/5/7/25 pcs

    Buffer

    1/3/5/7/25 pcs

    Swab

    1/3/5/7/25 pcs

    IFU

    1 pcs


    1

    2

    *Product images are for illustrative purposes only and may differ from the actual product.  Goldsite Diagnostics Inc. reserves the right to change the packaging design at anytime.

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