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
Consumable Kits
GenBody COVID-19 Ag Training Video
GenBody COVID-19 Rapid Antigen Test Positive and Negative External Controls
GenBody COVID-19 Point-of-Care Antigen Test Training & Unboxing Video
Product overview and instructions for use of GenBody COVID-19 Ag TestGenBody COVID-19 Ag Training VideoThe video provides an overview of the product, the components included and explains the test procedures and results interpretation
GenBody COVID-19 Rapid Antigen Test Positive and Negative External Controls - POCGenBody COVID-19 Rapid Antigen Test Positive and Negative External Controlsthe video describes how to perform positive and negative external controls before Testing
COVID-19 Antigen Rapid Test Kit Unboxing and DemonstrationGenBody COVID-19 Point-of-Care Antigen Test Training & Unboxing VideoThe video covers GenBody COVID-19 Antigen Test Kit Unboxing and Demonstration
GenBody COVID-19 Ag Training Video
