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Flowflex Home Test COVID-19 Antigen OTC 10/Bx

Flowflex L031-118B5 Home Test COVID-19 Antigen

Medical Diagnostic & Emergency / Laboratory - Medical / 1414132 | Acon Laboratories, Inc - L031-118B5
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Flowflex Home Test COVID-19 Antigen OTC 10/Bx
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  • Categoría:
    Medical Diagnostic & Emergency / Laboratory - Medical / Rapid Diagnostic Test Kits / Respiratory
  • UNSPSC:
    41116100

Descripción del producto Resumen de las funciones del producto

  • • This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for non-prescription use.
  • • This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
  • • 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[1]3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

    • Especificaciones Especificaciones y medidas de los productos

    • Brand
      Flowflex
    • CLIA Classification
      OTC
    • Item
      COVID-19 Antigen
    • Item Type
      Home Test
    • Secondary Size
      Single Test

    Description du catalogue Tal como se ve en nuestro catálogo impreso

    Tests for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset. The test can also be used by individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. This test has been authorized for non-prescription use with self-collected specimens from individuals age 14 and older or with adult collected specimens from individuals 2 years or older. One test only required. No serial testing needed.

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