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COVID-19 Antigen Schnelltestkit


Overview:

The COVID-19 Antigen Rapid Test Kit is an immunochromatographic intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.

  

Benefits:

Rapid answers for patients: test results in 15 minutes

Reliable, high performance: Sensitivity: 96.5% / Specificity: 99.7%

Deploy at point of care in a variety of settings

Accessible solution enables large scale testing

Room temperature storage or refrigerated (4-30⁰C)

 

Specifications:

Test time: 15 minutes

Sensitivity:96.5%

Specificity:99.7%

CE MARK

Sample type: Nasopharyngeal swab and oropharyngeal swab

Quantity: 20 tests/kit


General Importeur for Germany: 

Handelshaus Lerch e.K.

Vogelbeerenstraße 30

17039 Wulkenzin OT Neuendorf


Telefon  +49(0)395 5665868

Mobil     +49(0)174 3225639

Fax.        +49(0)395 5821037

E-Mail: info@handelshaus-lerch.de

Ust ID: DE 279146932

HRB: HRA2488

Homepage: www.Handelshaus-lerch.de

Instruction for Use(For Professional Use):


IFU for COVID-19 Antigen Schnelltestki(professionellen Gebrauch geeignet).pdf


Instruction for Use(For Self-testing):


Final Covid-19 Antigen Rapid Test Kit(Saliva).pdf


Final Covid-19 Antigen Rapid Test Kit(Short Nose).pdf


 Clinical Validation Report:


Covid-19 Antigen Rapid Test Kit(Saliva).pdf


Covid-19 Antigen Rapid Test Kit(Short Nose).pdf


Covid-19 Antigen Rapid Test Kit.pdf


Beier nasal  clinical report.PDF