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

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