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Sofia 2 Starter Bundle Immunoassay Ea

Sofia 2 20395 Starter Bundle Immunoassay

Laboratory / Rapid Diagnostic Test Kit / 1389832 | Quidel - Sofia Line - 20395
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  9. Sofia 2 Starter Bundle Immunoassay Ea
Sofia 2 Starter Bundle Immunoassay Ea
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Product Overview Product feature summary

  • • This Test Has Not Been FDA Cleared Or Approved;

  • • The Test Has Been Authorized By FDA Under An Emergency Use Authorization (EUA) For Use By Authorized Laboratories.

  • • "Authorized Laboratories" Include Laboratories Certified Under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42U.S.C. §263a, That Meet The Requirements To Perform Moderate, High Or Waived Complexity Tests. This Test Is Also Authorized For Use At The Point Of Care (POC), i.e., In Patient Care Settings Operating Under A CLIA Certificate Of Waiver, Certificate Of Compliance, Or Certificate Of Accreditation.

  • • This Test Has Been Authorized Only For The Detection Of Proteins From SARS-CoV-2, And Influenza, Not For Any Other Viruses Or Pathogens.

  • • The Sofia 2 Flu + SARS Antigen FIA Is A Lateral Flow Immunofluorescentassay Used With The Sofia 2 Instrument Intended For The Simultaneous Qualitative Detection And Differentiation Of The Nucleocapsid Protein Antigens From SARS-CoV-2, Influenza A And Influenza B In Direct Nasopharyngeal (NP) And Nasal (NS) Swab Specimens From Individuals Suspected Of Respiratory Viral Infection Consistent With COVID-19 By Their Healthcare Provider Within The First Five Days Of The Onset Of Symptoms.

  • • The United States (U.S.) FDA Has Made This Test Available Under An Emergency Access Mechanism Called An Emergency Use Authorization (EUA). The EUA For This Test Is In Effect For The Duration Of The COVID-19 Emergency, Unless Terminated Or Revoked (after Which The Test May No Longer Be Used). An FDA Approved Or Cleared IVD Should Be Used Instead Of An IVD Under EUA, When Applicable And Available.

Catalog Description As seen in our print catalog

Uses advanced immunofluorescence-based lateral-flow technology in a sandwich design for qualitative detection and differentiation of nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal and nasal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first 5 days of the onset of symptoms. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes.
(Artist Note: Please move the following copy to beginning of Note section, after last item code, once module is on the page. Due to db character limitations, can't put it there in Stibo. Remove italics after moving copy.)
This test has not been FDA cleared or approved.
The test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by Authorized Laboratories.
"Authorized Laboratories" include laboratories certified under the Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42U.S.C. §263a, that meet the requirements to perform Moderate, High or Waived Complexity Tests. This test is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

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