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Visby Medical COVID-19/Flu A&B PCR Test Starter Kit CLIA Waived Ea

Visby Medical PS-400532 COVID-19/Flu A&B PCR Test Starter Kit

Laboratory / Rapid Diagnostic Test Kit / 1457223 | Visby Medical Inc. - PS-400532
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Visby Medical COVID-19/Flu A&B PCR Test Starter Kit CLIA Waived Ea
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  • Visby Medical COVID-19/Flu A&B PCR Test Starter Kit CLIA Waived Ea 1457223 | Visby Medical Inc. - PS-400532

  • Description:
    Visby Medical COVID-19/Flu A&B PCR Test Starter Kit CLIA Waived Contains 40 tests, 1 power adapter, 1 set of controls Each
  • Category:
    Laboratory / Rapid Diagnostic Test Kit
  • UNSPSC:
    41116100
  • Packaging Options (1)
    • Discontinued

Product Overview Product feature summary

Features & Benefits:

    • • This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories
    • • This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, 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

Specifications Product specifications and dimensions

  • Additional Attributes
    Contains 40 tests, 1 power adapter, 1 set of controls
  • Brand
    Visby Medical
  • CLIA Classification
    CLIA Waived
  • Item
    PCR Test Starter Kit
  • Item Type
    COVID-19/Flu A&B
  • Quantity
    Each

Catalog Description As seen in our print catalog

Authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral RNA in health care provider-collected nasopharyngeal and anterior nasal swab specimens, and health care provider-instructed self-collected anterior nasal swab specimens (collected on site) from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19.

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