Visby Medical
COVID-19 Test

Downloads

Below are resources to help run a successful test.

Visby Medical COVID-19 Point of Care Test Downloads for CLIA-waived Laboratories

• Quick Reference Guide
• Package Insert (Instructions for Use)
• Mid-Turbinate Dual Nostril Specimen Collection Instructions
• Dual Nostril Anterior Nasal Specimen Collection Instructions
• Nasopharyngeal Specimen Collection Instructions
• Fact Sheet for Patients
• Fact Sheet for Healthcare Providers
• COVID-19 Test Variant Coverage Technical Memo

Visby Medical COVID-19 Test Downloads for Moderate* and High Complexity Laboratories

• Quick Reference Guide (UTM)
• Quick Reference Guide (Pooling)*
• Package Insert (Instructions for Use)
• Fact Sheet for Healthcare Providers
• Fact Sheet for Patients
• COVID-19 Test Variant Coverage Technical Memo
• *Pooling not applicable to Moderate Complexity Laboratories

The Visby Medical COVID-19 Point of Care Test and Visby Medical COVID-19 Test have not been FDA cleared or approved; they have been authorized by FDA under an EUA for use by authorized laboratories. These tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.