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GENSURE 2019-NCOV ANTIGEN RAPID TEST (LATERAL FLOW) IS AN IMMUNOCHROMATOGRAPHIC ASSAY FOR THE RAPID IDENTIFICATION OF THE NEW CORONAVIRUS (2019-NCOV) ARISING FROM ANTIGENS EXTRACTED FROM SAMPLES TAKEN VIA NASAL AND NOSOPHARYNGAL SWABS.
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DETECTION TIME 10/15 MINUTES.
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THE TEST IS EASY TO PERFORM AND REQUIRES A FEW STEPS TO PERFORM.
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NO CONTAINMENT OR PREVENTION MEASURES SUCH AS BIOHAZARD HOODS ARE NECESSARY.
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IT IS POSSIBLE TO ANALYZE SAMPLES STORED IN VIRAL TRANSPORT MEDIA WITH OR WITHOUT ACTIVATOR.
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FOR PROFESSIONAL USE ONLY
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NASAL OR NOSOPHARYNGAL SWABS ARE PACKAGED INDIVIDUALLY
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LATEX FREE, PHTHALATE FREE, APYROGEN.
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FREE FROM PCR INHIBITORS FOR THE RESEARCH OF SARS COV2
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BELONG TO THE WANTED PATHOGENS
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SENSITIVITY: 96.6% (93.29% ~ 98.84%)
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SPECIFICITY: 100% (9, 97% 100%)
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TOTAL AGREED: 9, 91% (97.63% ~ 99.60%) LOD: 96.86%
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EN ISO 13485: 2016
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ISO 18113-2: 2013
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ISO 15223-1: 2016
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ISO 23640: 2015
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ISO 13641: 2002
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ISO 14971: 2012
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ISO 175511: 2003
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CE N.1434-IVDD-221/2022
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1 TEST BOX
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1 STERILE SWAB
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1 TUBE WITH PRE-FILLED BUFFER SOLUTION
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1 CAP FOR TUBE WITH DOSER
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1 BAG FOR BIOLOGICAL WASTE