Collections / OTC/Home Tests / CareStart Covid-19 Antigen Home Test

CareStart Covid-19 Antigen Home Test

CareStart Covid-19 Antigen Home Test

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CareStart - COVID OTC Rapid Antigen Test Kits – Box of 2 Tests

Features:

  • FDA EUA for at-home use
  • Lateral flow immunochromatographic assay
  • Using anterior nasal swab (appropriate for self-collection)
  • Test results are interpreted at 10 minutes after sample loading
  • Visual Read or App Read for result interpretation (no instrument required)
  • Digital guide for self sample collection and self-testing (digital IFU in mobile application)
  • 2D-barcode on each device; ensuring traceability of device (manufacturing information)
  • Digital connectivity: automatic result reporting to local and federal health authorities

Kit Components:

  • 2 Test Devices
  • Extraction Vials and Caps
  • 2 Nasal Swabs
  • Fact Sheet for Individuals

Documentation:

Fact Sheet For Healthcare Providers

Fact Sheet For Individuals

IFU (Instructions For Use)

User Instructions

FDA Emergency Use Authorization Letter

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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.