This Item Is A Control For The Solana Sars-CoV-2 Test Kit. That Test Has Not Been FDA Cleared Or Approved, But It Has Been Authorized For Emergency Use By FDA Under An EUA For Use By Authorized Laboratories. The Solana SARS-CoV-2 Assay Is An Isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) Assay Intended For The Qualitative Detection Of Nucleic Acid From SARS-CoV-2 In Nasopharyngeal (NP) And Nasal (NS) Swab Specimens From Individuals Suspected Of COVID-19 By Their Healthcare Provider. Testing Is Limited To Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42 U.S.C. §263a, To Perform High Or Moderate Complexity Tests. This Product Has Been Authorized Only For The Detection Of Nucleic Acid From SARS-CoV-2, Not For Any Other Viruses Or Pathogens. The Emergency Use Of This Product Is 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 Declaration Is Terminated Or Authorization Is Revoked Sooner.