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The AMPER COVID-19 Antigen rapid testing kit (Colloidal Gold) is in CIBG Listing

Date:2020-09-07
On September 3, 2020, Netherlands CIBG lists the AMPERTM COVID-19 Antigen rapid testing kit (Colloidal Gold) in the government-based web, indicating that the product has obtained the permission of EU market and other countries that accept CE mark.
The AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) is a colloidal gold-based lateral flow immunoassay, intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) specimens from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity and high complexity. 

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