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LEPU SARS-CoV-2 Antigen Rapid Test Kit brochure

LEPU SARS-CoV-2 Antigen Rapid Test Kit brochure
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LEPU SARS-CoV-2 Antigen Rapid Test Kit brochure - 1

SARS-COV2 Antigen Rapid Test Kit Colloidal Gold Immunochromatography

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Product Feature Convenient, no devices required S Rapid, get result in 15 minutes Stable, with high accuracy Inexpensive, cost-eﬃciency

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The test card contains a gold-labeled novel coronavirus N protein monoclonal antibody pre-coated on the binding pad and a paired novel coronavirus N protein monoclonal antibodies ﬁxed in the test line (T) and corresponding antibodies in the quality control line (C). N protein C Line monoclonal antibody Chromatographic direction Paired N protein monoclonal antibody SARS-COV2 Antigen Rapid Test Kit can detect the virus from ﬁrst phase of infect (2-3 days before potential symptom onset) to last phase of infection (7-10 days after potential symptom onset). Progression of infection Molecular...

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Clinical performance A total of 508 clinical specimens based on nucleic acid assay (PCR) were collected, including 243 positive specimens and 265 negative specimens. After comparing this product with nucleic acid assay (PCR) through the collected clinical samples, the results are summarized as follows: SARS-COV2 Antigen Rapid Test Kit Nucleic acid assay (PCR) Positive Performance against the Comparator Method-by Cycle Threshold Counts. SARS-COV2 Antigen Rapid Test Kit Nucleic acid assay (PCR) Positive(Ct≤32)

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Step 2: Peel oﬀ adhesive. Step 3: Insert swab from well B to well A. collect sample. Step 4: a. Add 6 drops of buﬀer to well A b. Rotate the shaft, two rounds each direction. Step 5: Fold left side over, and wait for 15 minutes. Result Interpretation

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Product speciﬁcations Test Site Corporation Mass Screening

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EU Common List of COVID-19 Rapid Antigen Tests EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Public health, country knowledge, crisis management Health Security and Vaccination EU health preparedness: A common list of COVID-19 rapid antigen tests, including those whose test results are mutually recognised, and a common standardised set of data to be included in COVID-19 test result certif icates Agreed by the Health Security Committee on 17 February 2021 III. Rapid antigen tests of which the test results are mutually recognised As stipulated in point 15 of the Council...

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Manufacture Address: Beijing Lepu Medical Technology Co., Ltd. Building 7-1 No.37 Chaoqian Road, Changping District, Beijing, 102200, P.R. China European Representative: Lepu Medical (Europe) Cooperatief U.A. Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The Netherlands Product information: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) Model: 1 test/kit; 5 tests/kit; 10 tests/kit; 25 tests/kit; 50 tests/kit Others (not in List A and List B) Conformity Assessment Route: Section 2 to 5 in annex III of IVDD 98/79/EC We herewith declare that the above mentioned...

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Annex 1 EN ISO 13485:2016 Medical devices – quality management systems - requirements for regulatory purposes EN ISO 14971:2019 Medical devices – application of risk management to medical devices EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices EN ISO 18113-1:2011 In vitro diagnostic medical devices – information supplied by the manufacturer (labelling) – Part 1: terms, definitions and general...

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