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TEST SYSTEM KIT RAPID SARS-COV-2 ANTIGEN POC CLARITY MADE FINLAND (25/BX 49BX/CS)
500-CLARTK - TEST SYSTEM KIT RAPID SARS-COV-2 ANTIGEN POC CLARITY MADE FINLAND (25/BX 49BX/CS)
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Clinical
Documentation

These Clarity COVID-19 Antigen Rapid Test Cassettes can be used to test directly collected naso-pharyngeal swab specimens for fast and easy results in as little as 5 minutes. These tests should be ordered for the detection of COVID-19 antigen in individuals who are suspected of COVID-19 by their healthcare provider and who are within six days of symptom onset.

  • CLIA Waived under FDA Emergency Use Authorization (EUA)
  • POCT approved
  • Rapid results within 5 minutes
  • Relative Sensitivity: 87.5%
  • Relative Specificity: >98.9%

 

Kit Contents:

  • 25 Individually Pouched Test Cassettes
  • 25 Sterile Naso-Pharyngeal Swabs
  • 25 Buffer Tubes
  • 1 Negative Control Swab
  • 1 Positive Control Swab
  • 1 Work Station
  • 1 Package Insert
  • 1 Quick Start Guide

 

*This item is not eligible for return or refund

This product has not been FDA cleared or approved. The product has been authorized by the FDA under an EUA for use as a source control by the general public as well as by HCP in the healthcare setting to help prevent the spread of infection or illness during the COVID-19 pandemic. This product is authorized only for the duration of the declaration that circumstances exist to justify the authorization of emergency use of medical devices, including alternative products used as medical devices.


Manufacturer Information
Name: SALOFA OY
Mfg Item Code: 500-CLARTK
Brand Name: CLARITY
HCPC Code:

SALOFA OY
 
 
 

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