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Clarity COVID-19 Antigen Test
Clarity COVID-19 Antigen Test


 
This item is non-returnable and non-cancellable.
Our Price: $295.00




Product Code: CLA-COV19AG-VIS

Details
 
Note: This product can only ship to a medical or an educational facility.



The Clarity COVID-19 antigen rapid test casette is now EUA, CLIA Waived and POCT approved.

Features and Benefits
  • FDA Emergency Use Authorized, CLIA Waived and POCT approved.
  • Relative Sensitivity 87.5%
  • Relative Specificity: >98.9%
  • Fast and Easy – Positive results as fast as 5 minutes
  • Test Naso-Pharyngeal Swab immediately, or store at room temperature and test within 1 hour.
  • Naso-Pharyngeal Swab stored in a dry tube at 2-8c can be tested within 24 hours.
  • Shelf life is 12 months.
Important Information
  • The Clarity COVID-19 Antigen test can be used to test directly collected naso-pharyngeal swab specimens.
  • The Clarity COVID-19 Antigen test 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.
  • The Clarity COVID-19 Antigen test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity, moderate complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.



Materials Included
  • 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
CPT Code
  • 87811QW: SARS-CoV-2 detection by immunoassay with direct optical (ie, visual) observation.
  • National average reimbursement: $41.38
Documentation
FDA EUA Document

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