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BfArM Listed CE Marked COVID-19 Antigen Rapid Test Kit

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

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Germany BfArM 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



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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Goldsite Diagnostics Inc., founded in 1999, is a leading Chinese diagnostics manufacturer specializing in in-vitro diagnostics devices and reagents.

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