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This product is used for qualitative detection of the novel SARS-CoV-2 virus antigen in human throat swabs or nasal swabs. It meets the requirements of the In Vitro Diagnostics Directive (98/79/EEC) and the following harmonised standards:
EN ISO 14971:2012
EN ISO 18113-1:2011
EN ISO 18113-2:2011
– Sample collection options: oropharyngeal swab, nasal swab, nasopharyngeal swab and sputum (saliva)
– Packing specifications: bulk pack 25 kits / pack
– Rapid detection: result in 15 minutes
– High accuracy
– Easy to use
Manufacturer: New Gene (Hangzhou) Bioengineering Co., Ltd.