Summary

  • GenBody COVID-19 antigen tests for fast and accurate results
  • Quantity: 25 Tests/kit
  • Processing Time: 15-20 minutes
  • Includes: Test device, Extraction Solution, Extraction Tube, Dropper Tips, and Swabs
  • Identifies acute infection with 99.04% specificity
  • Detects the Sars-CoV-2 variants
  • Identifies acute infection with a 92.31% sensitivity and 99.04% specificity
  • For Professional use only
  • Kit Components: GenBody COVID-19 Ag Test Device, Extraction Solution, Extraction Tube, Dropper Tips, Sterilized Nasopharyngeal or Anterior Nasal Swabs, External Positive Control Swab, External Negative Control Swab, Instructions for Use (IFU), Quick Reference Instructions (QRI).
  • STORAGE AND STABILITY
  • • GenBody COVID-19 Ag kit should be stored between 2 to 30 °C (35.6 to 86 °F).
  • • Kit components in the GenBody COVID-19 Ag kit are stable until the expiration date printed on the label.
  • • The Test Device must remain in the sealed foil pouch until use.
  • Limitations: Authorized by FDA for use under an Emergency Use Authorization (EUA) Only.
  • Listings and approvals: FDA EUA (EUA Number: EUA210249)
  • Note: This test is not for use in at-home testing settings
  • 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

Consumable Kit Type: Antigen

Model: GenBody

Manufacturer SKU: GenBody Covid-19 Test

Unit of Measure: BOX of 25 EA

Helena

Marks & Listings: CE, FDA, EUA

Weight, Shipping: 1.5 lb

Package Type: Box

  • Video explaining the instructions for use of GenBody COVID-19 Ag Test GenBody COVID-19 Ag Training Video
  • Video describing how to perform positive and negative external controls before testing GenBody COVID-19 Rapid Antigen Test Positive and Negative External Controls
  • GenBody COVID-19 Antigen Rapid Test Kit Unboxing and Demonstration GenBody COVID-19 Point-of-Care Antigen Test Training & Unboxing Video
Video explaining the instructions for use of GenBody COVID-19 Ag Test
Video describing how to perform positive and negative external controls before testing
GenBody COVID-19 Antigen Rapid Test Kit Unboxing and Demonstration
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