,for, Item ID-
  • #1301525
  • Sekisui Diagnostics #1099

Respiratory Test Kit OSOM® COVID-19 / Flu A + B Combo Test 25 Tests CLIA Waived

TEST, RESPTRY 510K CLIA F/COVID-19/FLU A&B (25/KT 18KT/CS)

Features

  • OSOM® COVID-19/Flu A&B Combo Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection
  • All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management
  • Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions
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Product Specifications


Features
  • OSOM® COVID-19/Flu A&B Combo Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection
  • All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management
  • Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions
  • Positive results do not rule out bacterial infection or co-infection with other viruses
  • The test strip enclosed in a cassette housing is comprised of the following components: sample pad, reagent pad, biotin pad, reaction membrane, and absorbent pad
  • CLIA waived for use with anterior nasal swab samples
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