PRODUCT
Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit(PCR-Fluorescence Probing)

Introduction

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.

Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment.  Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.


Advantages

  • One-tube technology, extraction within 30minutes

  • Up to 96 samples at one time

  • Simple operation process, no need long term staff training

  • Room temperature nucleic acid lysis, No heating

  • Direct sample types include: Nasal, Throat, and Nasopharyngeal swabs

  • Enhance screening efficiency

  • Internal control: human housekeeping gene RNase P


Parameters

  • Technology: One-tube fast test/ Mag-beads

  • Sensitivity: 200copies/mL

  • Lysis: Room temperature lysis

  • Sample types: Alveolar lavage fluid; throat swab, sputum

       (varys in different registration version)


Certificates

CE-IVD, NMPA, FDA-EUA, Brazil ANVISA etc.

FDA-EUA: Instruction for Use and fact sheet for healthcare providers, fact sheet for patients are available at  https://www.fda.gov/medical-devices/emergency-situations


Download

EUA-Sansure-kit-ifu-v2.pdf

EUA-Fact sheet for healthcare-Sansure-kit.pdf

EUA-Fact sheet for patients-Sansure-kit.pdf

20200506 Manual-Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)V02-A3 Version CE版.pdf

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tel:+86-0731-89736996
fax:+86 0731-88884876

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